A Phase 1/2 interventional study of JCAR017 and Durvalumab in Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse and Lymphoma, Follicular, sponsored by Celgene. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 1/2, Interventional, and Treatment
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Among 50 studies in Lymphoma, Non-Hodgkin by Bristol-Myers Squibb — 2 open to participants now, 5 under way, none of them phase 3. Lymphoma, Non-Hodgkin · Bristol-Myers Squibb.
Among the 50 studies in Lymphoma, Non-Hodgkin by Bristol-Myers Squibb, this one is the 23rd largest by enrollment of the 46 interventional ones that give a count, is one of 2 that started in 2017, is one of 9 in phase 1/2, and was the 30th registered.
2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 286 are open to participants now.
Browse Lymphoma, Non-Hodgkin studies →2 of the 50 studies in Lymphoma, Non-Hodgkin by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in United States, Chile, China and 12 more countries
Ages 18+
Bristol-Myers Squibb · Sites in United States, Germany, Japan and 1 more country
By country, each count listing its studies:
Of the 245 Lymphoma, Non-Hodgkin studies recruiting now, 145 (59%) set no upper age limit and 77 (31%) stop at 75 or younger; 68 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 23 · Phase 3 6
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 62 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.
Median enrollment 58 across the 46 interventional studies, 43 across the 4 observational. Of the 42 that completed or were terminated, 25 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Celgene, one of the names counted as Bristol-Myers Squibb. Under that name alone:
Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
3 of the studies in Lymphoma, Non-Hodgkin by Bristol-Myers Squibb that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05688475Bristol-Myers SquibbA Rollover Study of CC-122 | 2026-11-30 |
| NCT03930953CelgeneA Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) | 2027-04-07 |
| NCT06090539Bristol-Myers SquibbA Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas | 2027-10-28 |
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Among the 50 studies in Lymphoma, Non-Hodgkin by Bristol-Myers Squibb, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a global, open-label, multi-arm, parallel multi-cohort, multi-center, Phase 1/2 study to determine the safety, tolerability, PK, efficacy and patient-reported quality of life of JCAR017 in combination with various agents. This protocol is intended to evaluate various drug combinations with JCAR017, as separate arms, over the life of the protocol, using the same objectives. Each combination will be evaluated separately (ie, the intention is not to compare between combinations) for the purposes of the objectives, trial design, and statistical analysis. The following combinations will be tested:
Arm A: JCAR017 in combination with durvalumab Arm B: JCAR017 in combination with CC-122 (avadomide) Arm C: JCAR017 in combination with CC-220 (iberdomide) Arm D: JCAR017 in combination with ibrutinib Arm E: JCAR017 in combination with relatlimab and/or nivolumab Arm F: JCAR017 in combination with CC-99282 Additional arms will be added by way of amendment once combination agents have been selected.
The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.
During Phase 1, different arms may be opened to test JCAR017 in combination with combination agent(s) in adult subjects with R/R aggressive B-cell NHL. Within each arm, different doses and schedules of JCAR017 and the combination agent(s) may be tested in several cohorts and subcohorts per arm. During Phase 2 of the study, the expansion of any dose level and schedule for any arm that has been shown to be safe may occur.
Arm A will test JCAR017 in combination with Durvalumab Arm B will test JCAR017 in combination with CC-122 Arm C will test JCAR017 in combination with CC-220 (iberdomide ) Arm D will test JCAR017 in combination with ibrutinib. Arm E will test JCAR017 in combination with relatlimab and/or nivolumab Arm F will test JCAR017 in combination with CC-99282 All subjects from Phase 1 and Phase 2 will be followed for 24 months following JCAR017 infusion. Post-study follow-up for survival, relapse, long-term toxicity (including new malignancies), and viral vector safety will continue under a separate long-term follow-up (LTFU) protocol for up to 15 years after the JCAR017 dose as per health authority regulatory guidelines.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must have aggressive B-cell NHL according to "the 2016 revision of the WHO classification of lymphoid neoplasms", confirmed at last relapse by the treating institution, defined as:
Subject must have
Exclusion Criteria:
Subjects with prior history of , other than aggressive R/R NHL, unless the subject has been free of the disease for ≥ 2 years with the exception of the following non-invasive malignancies:
Prior treatment with the combination agent from the assigned arm:
Presence of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
JCAR017 will be administered at a single flat dose of 50 x 10\^6 CAR+T cells or 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules
Biological: JCAR017 · Drug: Durvalumab
This arm will test JCAR017 in combination with the CC-122. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses
Biological: JCAR017 · Drug: CC-122
This arm will test JCAR017 in combination with CC-220. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses
Biological: JCAR017 · Drug: CC-220
This arm will test JCAR017 in combination with ibrutinib. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at a fixed dose of 420 mg daily
Biological: JCAR017 · Drug: Ibrutinib
This arm will test JCAR017 in combination with relatlimab and/or nivolumab in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules
Biological: JCAR017 · Drug: Relatlimab · Drug: Nivolumab
This arm will test JCAR017 in combination with CC-99282 in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules.
Biological: JCAR017 · Drug: CC-99282
Gene modified autologous T cells
Anti-PD-L1
Also known as: MEDI4736
Pleiotropic Pathway Modifier
Ibrutinib
CC-220
Relatlimab
Nivolumab
CC-99282
Number of Participants With Dose-Limiting Toxicity (DLT)
Participants enrolled in Phase 1 are considered evaluable for DLTs if they received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and completed the specified DLT evaluation period or if they have received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and experience a DLT during the DLT evaluation period.
Time frame: From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)
Complete Response Rate (CRR)
Percentage of participants achieving a complete response (CR). CR is complete radiologic response (CRR) and complete metabolic response (CMR). CR was measured using CT and PET and assessed for the presence of index and non-index lesions, spleen size, and the absence of new lesions or diseased bone marrow. To be considered as having CRR participants had to have all of the following: * Index lesions - longest transverse diameter of nodal lesions ≤ 1.5 cm and the absence of extranodal disease. * Non-index lesions - the absence of non-index lesions. * Spleen size \<13 cm * The absence of new lesions * Normal bone marrow assessment To be considered as having CMR participants had to have all of the following: * A score of 1, 2, or 3 with or without residual mass on 5-PS for index and non-index lesions. * The absence of new lesions * No evidence of FDG-avid disease in marrow and a normal bone marrow assessment
Time frame: At 3 and 6 months post-JCAR017 infusion.
European Organisation for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30) Scores - Phase 2
The EORTC QLQ-C30 is composed of five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire is scored on a 4-point Likert response scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. The raw score is calculated as the average of the items that contribute to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales (physical, role, emotional, social, cognitive and global health) higher scores indicate better QoL. For symptom scales (fatigue, nausea and vomiting and pain) and single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) lower scores indicate fewer symptoms, i.e. better QoL.
Time frame: At baseline and 29 days and 57 days post JCAR017 dose
EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) Scores - Phase 2
The EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are scored from 0 to 100 i.e., 'The worst health you can imagine' (score of 0) to 'The best health you can imagine' (score of 100). Higher scores indicate better health outcomes.
Time frame: At baseline and 1, 29, 57, 85, 180, 270, 365, 545, and 730 days post JCAR017 dose
Number of Participants With Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) is also considered an AE. All participants were monitored for AEs during the study. Assessments included monitoring of any or all of the following parameters: the participant's clinical symptoms, laboratory, pathological, radiological or surgical findings, physical examination findings, or findings from other tests and/or procedures.
Time frame: Up to 3 months after the dose of JCAR017 or after the last dose of the combination agent, whichever occurred last (an average of 6.5 months up until a max of 9.5 months)
Number of Participants With Severe Adverse Events (SAEs)
An SAE is any AE occurring at any dose that: * Results in death; * Is life-threatening (i.e., in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay); * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event.
Time frame: Up to 3 months after the dose of JCAR017 or after the last dose of the combination agent, whichever occurred last (an average of 6.5 months up until a max of 9.5 months)
Change From Baseline in White Blood Cell and Platelet Numbers
White blood cell, and platelet counts. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Percent of White Blood Cells
Change from baseline in percent of white blood cells was measured using differential blood tests. A differential blood test is a blood test that measures the percentage and number of each type of white blood cell (WBC) - neutrophils, lymphocytes, monocytes, eosinophils and basophils - as well as abnormal cell types if they are present. These results are reported as percentages and absolute values, and compared against reference ranges to determine whether the values are normal, low, or high. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline Erythrocyte Numbers
Change from baseline in erythrocyte (also known as red blood cell) numbers was measured using a test called a red blood cell count. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline Hematocrit Ratio
The change in the proportion of red blood cells in the blood was measured using a hematocrit test. A hematocrit test measures the volume of packed red blood cells relative to whole blood. This is represented as a ratio. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Hemoglobin Levels
The change from baseline in hemoglobin levels was measured using a hemoglobin test. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is a protein in red blood cells that carries oxygen from the lungs to the rest of the body. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Specific Liver Serum Enzyme Levels
Change from baseline in alanine aminotransferase (ALT) alkaline phosphatase (ALP), and aspartate aminotransferase (AST). Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Specific Serum Protein Levels
Change from baseline in serum albumin and protein levels. Serum protein level tests are blood tests that measure the number of proteins in the blood. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Serum Beta-2-Microglobulin Levels
Change from baseline in serum Beta-2-Microglobulin levels was measured using a beta-2 microglobulin (B2M) tumor marker test. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Serum Bicarbonate Levels
Change from baseline in serum bicarbonate levels was measured using a serum bicarbonate test. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 85 days after the dose of JCAR017 for Arms A, B, D, E, and F; 57 days after the dose of JCAR017 for Arm C
Change From Baseline in Coagulation Times
Change from baseline in activated partial thromboplastin and prothrombin times. Activated partial thromboplastin time and prothrombin time are blood tests that measure how long it takes for blood to form a clot. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 57 days after the dose of JCAR017
Change From Baseline in D-Dimer Levels
D-dimer is a substance that is produced in the body when blood clots are broken down. The D-dimer laboratory test measures the level of D-dimer in the blood and is often used to help diagnose or rule out conditions related to blood clotting, such as deep vein thrombosis (DVT) or pulmonary embolism (PE). Elevated levels of D-dimer may indicate the presence of a blood clot, but other factors can also cause an increase in D-dimer levels. Therefore, the D-dimer test is typically used in combination with other diagnostic tests to help make an accurate diagnosis. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 57 days after the dose of JCAR017
Change From Baseline in Fibrinogen Levels
Fibrinogen is a protein that plays a role in a number of processes in the body, including blood clot formation, wound healing, inflammation, and blood vessel growth. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 57 days after the dose of JCAR017
Change From Baseline in Prothrombin International Normalized Ratio
The Prothrombin International Normalized Ratio (INR) is used to determine the clotting tendency of blood. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT. Baseline is defined as the last measurement on or prior to any study treatment.
Time frame: 57 days after the dose of JCAR017
Progression-Free Survival (PFS)
PFS is defined as time from JCAR017 infusion to disease progression or death from any cause. Progressive disease (PD) was measured using CT and PET as an increase in size index and non-index lesions, spleen size, and the presence of new lesions or diseased bone marrow. Summarized using Kaplan-Meier estimates.
Time frame: From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
Overall Survival (OS)
Time from JCAR017 infusion to death. Data from surviving participants was censored at the last time that the participant was known to be alive. Summarized using Kaplan-Meier estimates.
Time frame: From start of JCAR017 to time of death from any cause, or data cut-off date, whichever occurred first (up to approximately 62 months)
Overall Response Rate (ORR)
The ORR is the percent of participants achieving an objective response of partial response (PR) or better according to the Lugano Criteria for Response Assessment (Cheson, 2014), prior to start of another non-study anticancer therapy. Complete response (CR) assessed by CT-scan: * Index lesions: Nodal Disease: ≤ 1.5 cm in largest transverse diameter, Extranodal Disease: Absent * Non-index lesions: Absent, * Spleen: \<13 cm * New lesions: None * Bone marrow: Normal Partial response (PR) assessed by CT-scan: * Index lesions: \>=50% decrease from baseline in shortest diameter * Non-index lesions: No increase, * Spleen: \>50% decrease from baseline in enlarged portion * New lesions: None * Bone marrow: N/A Overall Response (OR) = CR + PR
Time frame: At 1, 3, 6, 9, 12, 18 and 24 months post-JCAR017 infusion
Duration of Response (DOR)
DOR is defined as the time from first response to disease progression or death from any cause. Summarized using Kaplan-Meier estimates.
Time frame: From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
Event-Free Survival (EFS)
EFS is defined as time from JCAR017 infusion to disease progression, starting a new antilymphoma therapy, or death from any cause, whichever occurred first.
Time frame: From JCAR017 infusion to disease progression or death from any cause (up to approximately 62 months)
Maximum Concentration (Cmax) of JCAR017 by qPCR
Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. qPCR was used to determine Cmax by detecting the JCAR017 transgene.
Time frame: Up to 24 months post- JCAR017 infusion
Time to Maximum Concentration (Tmax) of JCAR017 by qPCR
Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. qPCR was used to determine Tmax by detecting the JCAR017 transgene.
Time frame: Up to 24 months post- JCAR017 infusion
Total Exposure to JCAR017 as Measured by the Area Under the Curve (AUC) by qPCR
Area Under the Curve" (AUC) represents the total exposure of participants to study drug. qPCR was used to determine AUC by detecting the JCAR017 transgene.
Time frame: Up to 24 months post- JCAR017 infusion
Participants were only enrolled into the following groups: Arm A: Cohorts1 A and 1B, Arm B: Cohort 1A, Arm C: Cohort 1A, Arm D: Cohort 1A, Arm E: Cohort 1C, Arm F: Cohorts 1A and 1D.
| Milestone | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|---|---|
| Started | 11 | 9 | 13 | 1 | 17 | 2 | 7 | 2 |
| Completed | 8 | 8 | 11 | 1 | 16 | 2 | 5 | 2 |
| Not completed | 3 | 1 | 2 | 0 | 1 | 0 | 2 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Other reasons | 2 | 1 | 2 | 0 | 0 | 0 | 2 | 0 |
| Milestone | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|---|---|
| Started | 8 | 8 | 11 | 1 | 16 | 2 | 5 | 2 |
| Safety set | 8 | 8 | 11 | 1 | 17 | 2 | 4 | 2 |
| Completed | 6 | 5 | 4 | 0 | 12 | 2 | 3 | 0 |
| Not completed | 2 | 3 | 7 | 1 | 4 | 0 | 2 | 2 |
| Withdrew: Death | 1 | 2 | 0 | 0 | 1 | 0 | 2 | 0 |
| Withdrew: Adverse event | 0 | 1 | 4 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by participant | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
| Withdrew: Other reasons | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
Participants enrolled in Phase 1 are considered evaluable for DLTs if they received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and completed the specified DLT evaluation period or if they have received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and experience a DLT during the DLT evaluation period.
| Participants | Arm A: Cohort 1A and 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicity (DLT) | 0 | 2 | 1 | 1 | 0 | 0 |
Percentage of participants achieving a complete response (CR). CR is complete radiologic response (CRR) and complete metabolic response (CMR). CR was measured using CT and PET and assessed for the presence of index and non-index lesions, spleen size, and the absence of new lesions or diseased bone marrow. To be considered as having CRR participants had to have all of the following: * Index lesions - longest transverse diameter of nodal lesions ≤ 1.5 cm and the absence of extranodal disease. * Non-index lesions - the absence of non-index lesions. * Spleen size \<13 cm * The absence of new lesions * Normal bone marrow assessment To be considered as having CMR participants had to have all of the following: * A score of 1, 2, or 3 with or without residual mass on 5-PS for index and non-index lesions. * The absence of new lesions * No evidence of FDG-avid disease in marrow and a normal bone marrow assessment
| Percent of Participants | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| CRR at 3 Months | 71.4 (41.9 to 91.6) | 62.5 (24.5 to 91.5) | 0.0 (0.0 to 97.5) | 46.7 (21.3 to 73.4) | 0.0 (0.0 to 84.2) | 60.0 (14.7 to 94.7) |
| CRR at 6 Months | 78.6 (49.2 to 95.3) | 62.5 (24.5 to 91.5) | 0.0 (0.0 to 97.5) | 53.3 (26.6 to 78.7) | 0.0 (0.0 to 84.2) | 60.0 (14.7 to 94.7) |
The EORTC QLQ-C30 is composed of five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire is scored on a 4-point Likert response scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. The raw score is calculated as the average of the items that contribute to the scale. The final scores are calculated via linear transformation of raw scores and range from 0 to 100. For functional scales (physical, role, emotional, social, cognitive and global health) higher scores indicate better QoL. For symptom scales (fatigue, nausea and vomiting and pain) and single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) lower scores indicate fewer symptoms, i.e. better QoL.
| Score on a scale | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Global Health Status - Baseline | 72.92 ± 20.140 | 80.95 ± 16.467 | — | — | — | — |
| Global Health Status - JCAR017 Day 29 | 70.24 ± 12.957 | 85.71 ± 20.813 | — | — | — | — |
| Global Health Status - JCAR017 Day 57 | 75.60 ± 13.660 | 89.29 ± 12.467 | — | — | — | — |
| Physical Functioning - Baseline | 80.00 ± 23.613 | 86.67 ± 13.333 | — | — | — | — |
| Physical Functioning - JCAR017 Day 29 | 80.48 ± 22.716 | 91.43 ± 10.690 | — | — | — | — |
| Physical Functioning - JCAR017 Day 57 | 81.90 ± 22.710 | 87.62 ± 15.119 | — | — | — | — |
| Role Functioning - Baseline | 68.06 ± 35.858 | 78.57 ± 28.406 | — | — | — | — |
| Role Functioning - JCAR017 Day 29 | 75.00 ± 30.487 | 88.10 ± 18.545 | — | — | — | — |
| Role Functioning - JCAR017 Day 57 | 77.38 ± 27.431 | 83.33 ± 25.459 | — | — | — | — |
| Emotional Functioning - Baseline | 77.08 ± 21.059 | 85.71 ± 12.467 | — | — | — | — |
| Emotional Functioning -JCAR017 Day 29 | 86.90 ± 16.894 | 91.67 ± 12.729 | — | — | — | — |
| Emotional Functioning - JCAR017 Day 57 | 85.71 ± 16.803 | 89.29 ± 10.446 | — | — | — | — |
| Cognitive Functioning - Baseline | 81.94 ± 18.060 | 95.24 ± 8.133 | — | — | — | — |
| Cognitive Functioning - JCAR017 Day 29 | 88.10 ± 13.757 | 92.86 ± 13.113 | — | — | — | — |
| Cognitive Functioning - JCAR017 Day 57 | 94.05 ± 12.416 | 92.86 ± 13.113 | — | — | — | — |
| Social Functioning - Baseline | 69.44 ± 36.121 | 76.19 ± 23.288 | — | — | — | — |
| Social Functioning - JCAR017 Day 29 | 69.05 ± 21.540 | 88.10 ± 15.853 | — | — | — | — |
| Social Functioning - JCAR017 Day 57 | 80.95 ± 20.524 | 85.71 ± 20.250 | — | — | — | — |
| Fatigue - Baseline | 37.96 ± 30.506 | 14.29 ± 16.623 | — | — | — | — |
| Fatigue - JCAR017 Day 29 | 26.98 ± 18.853 | 23.81 ± 18.624 | — | — | — | — |
| Fatigue - JCAR017 Day 57 | 32.54 ± 19.715 | 22.22 ± 22.222 | — | — | — | — |
| Nausea and Vomiting - Baseline | 11.11 ± 28.721 | 7.14 ± 13.113 | — | — | — | — |
| Nausea and Vomiting - JCAR017 Day 29 | 9.52 ± 15.627 | 7.14 ± 8.909 | — | — | — | — |
| Nausea and Vomiting - JCAR017 Day 57 | 9.52 ± 14.194 | 0.00 ± 0.00 | — | — | — | — |
| Pain - Baseline | 34.72 ± 35.146 | 16.67 ± 19.245 | — | — | — | — |
| Pain - JCAR017 Day 29 | 20.24 ± 29.365 | 16.67 ± 19.245 | — | — | — | — |
| Pain - JCAR017 Day 57 | 22.62 ± 30.387 | 14.29 ± 20.250 | — | — | — | — |
| Dyspnea - Baseline | 16.67 ± 17.408 | 4.76 ± 12.599 | — | — | — | — |
| Dyspnea - JCAR017 Day 29 | 21.43 ± 21.111 | 4.76 ± 12.599 | — | — | — | — |
| Dyspnea - JCAR017 Day 57 | 14.29 ± 17.118 | 4.76 ± 12.599 | — | — | — | — |
| Insomnia - Baseline | 41.67 ± 35.176 | 23.81 ± 25.198 | — | — | — | — |
| Insomnia - JCAR017 Day 29 | 16.67 ± 28.495 | 19.05 ± 14.29 | — | — | — | — |
| Insomnia - JCAR017 Day 57 | 35.71 ± 33.242 | 19.05 ± 17.817 | — | — | — | — |
| Appetite Loss - Baseline | 25.00 ± 32.177 | 14.29 ± 17.817 | — | — | — | — |
| Appetite Loss - JCAR017 Day 29 | 26.19 ± 26.726 | 9.52 ± 16.265 | — | — | — | — |
| Appetite Loss - JCAR017 Day 57 | 21.43 ± 28.063 | 4.76 ± 12.599 | — | — | — | — |
| Constipation - Baseline | 13.89 ± 30.011 | 4.76 ± 12.599 | — | — | — | — |
| Constipation - JCAR017 Day 29 | 11.90 ± 28.063 | 4.76 ± 12.599 | — | — | — | — |
| Constipation - JCAR017 Day 57 | 14.29 ± 17.118 | 0.00 ± 0.000 | — | — | — | — |
| Diarrhea - Baseline | 5.56 ± 12.975 | 9.52 ± 16.265 | — | — | — | — |
| Diarrhea - JCAR017 Day 29 | 7.14 ± 14.194 | 4.76 ± 12.599 | — | — | — | — |
| Diarrhea - JCAR017 Day 57 | 0.00 ± 0.000 | 9.52 ± 16.265 | — | — | — | — |
| Financial Difficulties - Baseline | 30.56 ± 36.121 | 28.57 ± 29.991 | — | — | — | — |
| Financial Difficulties - JCAR017 Day 29 | 19.05 ± 31.254 | 23.81 ± 31.706 | — | — | — | — |
| Financial Difficulties - JCAR017 Day 57 | 21.43 ± 30.959 | 28.57 ± 29.991 | — | — | — | — |
The EuroQol- 5 Dimensions of Health Visual Analogue Scale (EQ-5D VAS) records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are scored from 0 to 100 i.e., 'The worst health you can imagine' (score of 0) to 'The best health you can imagine' (score of 100). Higher scores indicate better health outcomes.
| Score on a Scale | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Baseline | 69.5 ± 21.83 | 82.6 ± 12.31 | — | — | — | — |
| JCAR017 Day 1 | 75.1 ± 13.62 | 89.1 ± 12.13 | — | — | — | — |
| JCAR017 Day 29 | 77.5 ± 18.93 | 90.9 ± 10.33 | — | — | — | — |
| JCAR017 Day 57 | 81.2 ± 16.20 | 90.3 ± 9.43 | — | — | — | — |
| JCAR017 Day 85 | 88.4 ± 8.47 | 93.0 ± 4.98 | — | — | — | — |
| JCAR017 Day 180 | 86.0 ± 10.68 | 90.8 ± 13.96 | — | — | — | — |
| Follow-up - Day 270 | 88.7 ± 7.50 | 96.0 ± 1.41 | — | — | — | — |
| Follow-up - Day 365 | 89.2 ± 15.22 | 98.0 ± 2.83 | — | — | — | — |
| Follow-up - Day 545 | 89.7 ± 0.58 | 95.0 ± NA | — | — | — | — |
| Follow-up - Day 730/EOS | 79.3 ± 15.84 | 96.3 ± 3.21 | — | — | — | — |
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) is also considered an AE. All participants were monitored for AEs during the study. Assessments included monitoring of any or all of the following parameters: the participant's clinical symptoms, laboratory, pathological, radiological or surgical findings, physical examination findings, or findings from other tests and/or procedures.
| Participants | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | 16 | 11 | 1 | 17 | 2 | 6 |
An SAE is any AE occurring at any dose that: * Results in death; * Is life-threatening (i.e., in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay); * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event.
| Participants | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Number of Participants With Severe Adverse Events (SAEs) | 10 | 7 | 1 | 6 | 2 | 3 |
White blood cell, and platelet counts. Baseline is defined as the last measurement on or prior to any study treatment.
| 10^9 cells/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| BASOPHILS (10^9/L) | 0.00 ± 0.009 | 0.03 ± 0.050 | 0.10 ± NA | -0.02 ± 0.038 | 0.05 ± 0.071 | 0.00 ± 0.075 |
| EOSINOPHILS (10^9/L) | 0.20 ± 0.134 | 0.20 ± 0.282 | 0.00 ± NA | 0.01 ± 0.062 | -0.05 ± 0.071 | 0.04 ± 0.057 |
| LYMPHOCYTES (10^9/L) | 0.40 ± 0.359 | 0.29 ± 0.138 | -0.60 ± NA | -0.20 ± 0.828 | 1.00 ± 0.707 | 0.87 ± 0.757 |
| MONOCYTES (10^9/L) | 0.19 ± 0.209 | 0.38 ± 0.295 | 0.20 ± NA | -0.27 ± 0.527 | 0.15 ± 0.212 | 0.21 ± 0.279 |
| NEUTROPHILS (10^9/L) | -1.69 ± 1.940 | -1.74 ± 1.312 | 2.30 ± NA | -4.98 ± 8.198 | 1.95 ± 3.889 | -2.47 ± 3.335 |
| PLATELETS (10^9/L) | -6.91 ± 59.184 | 25.57 ± 28.547 | -77.00 ± NA | -125.92 ± 107.421 | -0.50 ± 20.506 | -11.00 ± 111.146 |
Change from baseline in percent of white blood cells was measured using differential blood tests. A differential blood test is a blood test that measures the percentage and number of each type of white blood cell (WBC) - neutrophils, lymphocytes, monocytes, eosinophils and basophils - as well as abnormal cell types if they are present. These results are reported as percentages and absolute values, and compared against reference ranges to determine whether the values are normal, low, or high. Baseline is defined as the last measurement on or prior to any study treatment.
| Percent | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| BASOPHILS/LEUKOCYTES (%) | 0.40 ± 0.420 | 0.89 ± 1.002 | 0.00 ± NA | 0.20 ± 0.558 | 0.15 ± 0.778 | 0.88 ± 1.450 |
| EOSINOPHILS/LEUKOCYTES (%) | 1.24 ± 2.455 | 5.20 ± 6.491 | -1.00 ± NA | 1.02 ± 1.565 | -0.40 ± 0.283 | 1.45 ± 3.264 |
| LYMPHOCYTES/LEUKOCYTES (%) | 11.59 ± 7.902 | 9.29 ± 4.870 | -37.00 ± NA | 2.60 ± 20.07 | 8.65 ± 1.202 | 24.73 ± 12.156 |
| MONOCYTES/LEUKOCYTES (%) | 7.13 ± 3.955 | 11.43 ± 6.574 | -8.00 ± NA | 8.18 ± 14.077 | 1.30 ± 0.000 | 8.88 ± 2.724 |
| NEUTROPHILS/LEUKOCYTES (%) | -20.69 ± 8.997 | -26.81 ± 13.462 | 45.00 ± NA | -12.13 ± 30.712 | -8.75 ± 0.354 | -35.55 ± 11.865 |
Change from baseline in erythrocyte (also known as red blood cell) numbers was measured using a test called a red blood cell count. Baseline is defined as the last measurement on or prior to any study treatment.
| 10^12 cells/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline Erythrocyte Numbers | -0.11 ± 0.507 | -0.21 ± 0.376 | -0.34 ± NA | -0.10 ± 0.476 | 0.05 ± 0.148 | -0.10 ± 0.281 |
The change in the proportion of red blood cells in the blood was measured using a hematocrit test. A hematocrit test measures the volume of packed red blood cells relative to whole blood. This is represented as a ratio. Baseline is defined as the last measurement on or prior to any study treatment.
| Ratio | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline Hematocrit Ratio | 0.01 ± 0.048 | -0.02 ± 0.028 | -0.04 ± NA | 0.01 ± 0.048 | 0.02 ± 0.020 | -0.01 ± 0.039 |
The change from baseline in hemoglobin levels was measured using a hemoglobin test. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is a protein in red blood cells that carries oxygen from the lungs to the rest of the body. Baseline is defined as the last measurement on or prior to any study treatment.
| g/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline in Hemoglobin Levels | 0.45 ± 16.688 | -5.43 ± 12.869 | -12.00 ± NA | 1.38 ± 17.207 | 9.50 ± 13.435 | -2.50 ± 18.502 |
Change from baseline in alanine aminotransferase (ALT) alkaline phosphatase (ALP), and aspartate aminotransferase (AST). Baseline is defined as the last measurement on or prior to any study treatment.
| U/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| ALANINE AMINOTRANSFERASE (U/L) | 5.45 ± 5.429 | -2.86 ± 7.105 | -1.00 ± NA | -0.58 ± 11.237 | 0.50 ± 4.950 | 2.50 ± 2.082 |
| ALKALINE PHOSPHATASE (U/L) | 12.09 ± 47.526 | -2.43 ± 24.234 | 22.00 ± NA | -18.50 ± 19.806 | 3.50 ± 16.263 | -16.25 ± 11.295 |
| ASPARTATE AMINOTRANSFERASE (U/L) | 2.91 ± 5.467 | -4.43 ± 6.373 | -1.00 ± NA | 0.75 ± 7.008 | -5.50 ± 17.678 | -7.00 ± 7.439 |
Change from baseline in serum albumin and protein levels. Serum protein level tests are blood tests that measure the number of proteins in the blood. Baseline is defined as the last measurement on or prior to any study treatment.
| g/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| ALBUMIN (g/L) | 4.09 ± 5.281 | 2.29 ± 3.450 | 9.00 ± NA | 1.42 ± 4.926 | 6.00 ± 4.243 | 3.50 ± 9,747 |
| PROTEIN (g/L) | 3.91 ± 8.166 | 0.00 ± 3.697 | 16.00 ± NA | -4.17 ± 3.881 | -0.50 ± 0.707 | -2.50 ± 11.030 |
Change from baseline in serum Beta-2-Microglobulin levels was measured using a beta-2 microglobulin (B2M) tumor marker test. Baseline is defined as the last measurement on or prior to any study treatment.
| mg/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline in Serum Beta-2-Microglobulin Levels | 0.33 ± 0.735 | 0.06 ± 0.221 | -0.10 ± NA | -0.04 ± 1.019 | -0.65 ± 1.577 | 0.29 ± 0.654 |
Change from baseline in serum bicarbonate levels was measured using a serum bicarbonate test. Baseline is defined as the last measurement on or prior to any study treatment.
| mmol/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline in Serum Bicarbonate Levels | 0.91 ± 3.270 | 0.00 ± 4.509 | 0.00 ± NA | -0.50 ± 4.079 | 3 ± 2.828 | -0.50 ± 2.646 |
Change from baseline in activated partial thromboplastin and prothrombin times. Activated partial thromboplastin time and prothrombin time are blood tests that measure how long it takes for blood to form a clot. Baseline is defined as the last measurement on or prior to any study treatment.
| Seconds | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| ACTIVATED PARTIAL THROMBOPLASTIN TIME (SEC) | -5.70 ± 21.348 | -0.31 ± 5.423 | 2.40 ± NA | -2.25 ± 1.566 | 4.25 ± 6.859 | -2.10 ± 2.364 |
| PROTHROMBIN TIME (SEC) | -0.02 ± 0.732 | 1.07 ± 2.974 | 0.40 ± NA | -0.11 ± 0.479 | -2.90 ± 3.394 | 0.98 ± 2.695 |
D-dimer is a substance that is produced in the body when blood clots are broken down. The D-dimer laboratory test measures the level of D-dimer in the blood and is often used to help diagnose or rule out conditions related to blood clotting, such as deep vein thrombosis (DVT) or pulmonary embolism (PE). Elevated levels of D-dimer may indicate the presence of a blood clot, but other factors can also cause an increase in D-dimer levels. Therefore, the D-dimer test is typically used in combination with other diagnostic tests to help make an accurate diagnosis. Baseline is defined as the last measurement on or prior to any study treatment.
| mg/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline in D-Dimer Levels | -0.92 ± 1.789 | -0.13 ± 0.311 | -0.46 ± NA | -0.69 ± 1.601 | -0.39 ± 0.746 | 0.13 ± 0.241 |
Fibrinogen is a protein that plays a role in a number of processes in the body, including blood clot formation, wound healing, inflammation, and blood vessel growth. Baseline is defined as the last measurement on or prior to any study treatment.
| g/L | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline in Fibrinogen Levels | -0.23 ± 1.379 | -0.65 ± 1.697 | 2.59 ± NA | -2.04 ± 2.012 | -5.12 ± 1.888 | -1.77 ± 0.525 |
The Prothrombin International Normalized Ratio (INR) is used to determine the clotting tendency of blood. The INR is derived from prothrombin time (PT) which is calculated as a ratio of the patient's PT to a control PT. Baseline is defined as the last measurement on or prior to any study treatment.
| Ratio | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Change From Baseline in Prothrombin International Normalized Ratio | -0.01 ± 0.079 | 0.08 ± 0.234 | 0.10 ± NA | -0.01 ± 0.066 | -0.20 ± 0.283 | 0.10 ± 0.198 |
PFS is defined as time from JCAR017 infusion to disease progression or death from any cause. Progressive disease (PD) was measured using CT and PET as an increase in size index and non-index lesions, spleen size, and the presence of new lesions or diseased bone marrow. Summarized using Kaplan-Meier estimates.
| Months | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | 20.90 (2.96 to NA) | NA (2.30 to NA) | 2.86 (NA to NA) | NA (1.91 to NA) | 4.07 (2.17 to NA) | 3.06 (2.79 to NA) |
Time from JCAR017 infusion to death. Data from surviving participants was censored at the last time that the participant was known to be alive. Summarized using Kaplan-Meier estimates.
| Months | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Overall Survival (OS) | 31.34 (4.50 to 38.08) | NA (3.22 to NA) | 2.86 (NA to NA) | NA (9.46 to NA) | NA (7.26 to NA) | 6.60 (4.27 to NA) |
The ORR is the percent of participants achieving an objective response of partial response (PR) or better according to the Lugano Criteria for Response Assessment (Cheson, 2014), prior to start of another non-study anticancer therapy. Complete response (CR) assessed by CT-scan: * Index lesions: Nodal Disease: ≤ 1.5 cm in largest transverse diameter, Extranodal Disease: Absent * Non-index lesions: Absent, * Spleen: \<13 cm * New lesions: None * Bone marrow: Normal Partial response (PR) assessed by CT-scan: * Index lesions: \>=50% decrease from baseline in shortest diameter * Non-index lesions: No increase, * Spleen: \>50% decrease from baseline in enlarged portion * New lesions: None * Bone marrow: N/A Overall Response (OR) = CR + PR
| Percent of Participants | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Month 1 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 60.0 (32.3 to 83.7) | 100.00 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
| Month 3 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 73.3 (44.9 to 92.2) | 100.0 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
| Month 6 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 73.3 (44.9 to 92.2) | 100.0 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
| Month 9 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 73.3 (44.9 to 92.2) | 100.0 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
| Month 12 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 73.3 (44.9 to 92.2) | 100.0 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
| Month 18 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 73.3 (44.9 to 92.2) | 100.0 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
| Month 24 | 92.9 (66.1 to 99.8) | 75.0 (34.9 to 96.8) | 100.0 (2.5 to 100.0) | 73.3 (44.9 to 92.2) | 100.0 (15.8 to 100.0) | 60.0 (14.7 to 94.7) |
DOR is defined as the time from first response to disease progression or death from any cause. Summarized using Kaplan-Meier estimates.
| Months | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Duration of Response (DOR) | 21.45 (2.43 to NA) | NA (1.45 to NA) | 1.91 (NA to NA) | NA (17.71 to NA) | 3.15 (1.22 to NA) | 3.29 (1.87 to NA) |
EFS is defined as time from JCAR017 infusion to disease progression, starting a new antilymphoma therapy, or death from any cause, whichever occurred first.
| Months | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Event-Free Survival (EFS) | 20.90 (2.96 to NA) | NA (2.30 to NA) | 2.86 (NA to NA) | 18.76 (1.91 to NA) | 4.07 (2.17 to NA) | 3.06 (2.79 to NA) |
Cmax is the maximum or peak concentration of drug reached in the plasma following a dose of the drug. qPCR was used to determine Cmax by detecting the JCAR017 transgene.
| Copies/ug | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Maximum Concentration (Cmax) of JCAR017 by qPCR | 11464.7 ± 305.8 | 14087.1 ± 434.7 | 28845.0 ± NA | 28877.7 ± 314.2 | 58522.9 ± 63.5 | 18003.4 ± 343.4 |
Time to maximum concentration (Tmax) is the time it takes for a drug to reach the maximum concentration (Cmax) after administration. qPCR was used to determine Tmax by detecting the JCAR017 transgene.
| Days | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Time to Maximum Concentration (Tmax) of JCAR017 by qPCR | 10.0 (7.0 to 42.0) | 10.0 (7.0 to 19.0) | 29.0 (29.0 to 29.0) | 14.0 (7.0 to 28.0) | 10.0 (10.0 to 10.0) | 8.5 (7.0 to 10.0) |
Area Under the Curve" (AUC) represents the total exposure of participants to study drug. qPCR was used to determine AUC by detecting the JCAR017 transgene.
| Copies/ug*day | Arm A: JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A | Arm C: JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|
| Total Exposure to JCAR017 as Measured by the Area Under the Curve (AUC) by qPCR | 85169.458 ± 237.850 | 83155.476 ± 473.149 | 288951.250 ± NA | 281265.838 ± 360.545 | 529755.009 ± 9.534 | 190904.832 ± 224.399 |
Collected over Participants were assessed for All-Cause Mortality from the date of leukapheresis until study completion (assessed up to approximately 62 months). SAEs and Other AEs were assessed from leukapheresis to 90 days after last dose of study therapy (an average of 7.5 months up until a max of 10.5 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | 7/11 (63.6%) | 4/11 (36.4%) | 8/11 (72.7%) |
| Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | 7/9 (77.8%) | 6/9 (66.7%) | 8/9 (88.9%) |
| Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | 8/13 (61.5%) | 7/13 (53.8%) | 11/13 (84.6%) |
| Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | 5/17 (29.4%) | 6/17 (35.3%) | 17/17 (100%) |
| Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | 1/2 (50%) | 2/2 (100%) | 2/2 (100%) |
| Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | 4/7 (57.1%) | 3/7 (42.9%) | 4/7 (57.1%) |
| Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | 1/2 (50%) | 0/2 (0%) | 2/2 (100%) |
| Event | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|---|---|
| PainGeneral disorders | 0/11 | 0/9 | 0/13 | 1/1 | 0/17 | 0/2 | 0/7 | 0/2 |
| Failure to thriveMetabolism and nutrition disorders | 0/11 | 0/9 | 0/13 | 1/1 | 0/17 | 0/2 | 0/7 | 0/2 |
| Abdominal painGastrointestinal disorders | 0/11 | 0/9 | 0/13 | 0/1 | 0/17 | 1/2 | 0/7 | 0/2 |
| ConstipationGastrointestinal disorders | 0/11 | 0/9 | 0/13 | 0/1 | 0/17 | 1/2 | 0/7 | 0/2 |
| NeurotoxicityNervous system disorders | 1/11 | 1/9 | 2/13 | 0/1 | 2/17 | 1/2 | 1/7 | 0/2 |
| Cytokine release syndromeImmune system disorders | 0/11 | 1/9 | 3/13 | 0/1 | 0/17 | 0/2 | 0/7 | 0/2 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/11 | 2/9 | 0/13 | 0/1 | 0/17 | 0/2 | 0/7 | 0/2 |
| Acute kidney injuryRenal and urinary disorders | 1/11 | 2/9 | 0/13 | 0/1 | 0/17 | 0/2 | 0/7 | 0/2 |
| COVID-19Infections and infestations | 0/11 | 0/9 | 0/13 | 0/1 | 1/17 | 0/2 | 1/7 | 0/2 |
| HeadacheNervous system disorders | 0/11 | 0/9 | 0/13 | 0/1 | 0/17 | 0/2 | 1/7 | 0/2 |
| Event | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) |
|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/11 | 7/9 | 5/13 | 1/1 | 10/17 | 2/2 | 2/7 | 1/2 |
| HypofibrinogenaemiaBlood and lymphatic system disorders | 0/11 | 0/9 | 0/13 | 1/1 | 1/17 | 0/2 | 0/7 | 0/2 |
| NeutropeniaBlood and lymphatic system disorders | 2/11 | 5/9 | 8/13 | 1/1 | 5/17 | 2/2 | 1/7 | 0/2 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/11 | 4/9 | 7/13 | 1/1 | 2/17 | 2/2 | 0/7 | 0/2 |
| Sinus tachycardiaCardiac disorders | 0/11 | 0/9 | 1/13 | 1/1 | 0/17 | 1/2 | 0/7 | 0/2 |
| Abdominal painGastrointestinal disorders | 1/11 | 1/9 | 1/13 | 1/1 | 1/17 | 1/2 | 0/7 | 0/2 |
| Anal incontinenceGastrointestinal disorders | 0/11 | 0/9 | 0/13 | 1/1 | 1/17 | 0/2 | 0/7 | 0/2 |
| ConstipationGastrointestinal disorders | 0/11 | 3/9 | 3/13 | 1/1 | 1/17 | 0/2 | 0/7 | 0/2 |
| NauseaGastrointestinal disorders | 4/11 | 2/9 | 5/13 | 1/1 | 0/17 | 0/2 | 0/7 | 1/2 |
| FatigueGeneral disorders | 3/11 | 4/9 | 6/13 | 0/1 | 2/17 | 0/2 | 0/7 | 2/2 |
| Age, Continuous(Years) | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 61.9 ± 8.40 | 68.6 ± 6.65 | 60.8 ± 14.66 | 69.0 ± NA | 56.5 ± 12.19 | 66.5 ± 2.12 | 66.6 ± 14.14 | 55.0 ± 19.8 | 61.7 ± 11.92 |
| Sex: Female, Male(Participants) | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 3 | 3 | 1 | 0 | 7 | 0 | 4 | 1 | 19 |
| Male | 8 | 6 | 12 | 1 | 10 | 2 | 3 | 1 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 5 |
| Not Hispanic or Latino | 10 | 8 | 13 | 1 | 15 | 2 | 6 | 2 | 57 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion) | Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion) | Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion) | Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion) | Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion) | Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion) | Total |
|---|---|---|---|---|---|---|---|---|---|
| AMERICAN INDIAN OR ALASKA NATIVE | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| ASIAN | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 3 |
| BLACK OR AFRICAN AMERICAN | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 3 |
| WHITE | 9 | 9 | 12 | 1 | 11 | 2 | 6 | 1 | 51 |
| OTHER | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Feb 2023, 61 months.
Results were first posted in Apr 2024, 1 year 1 month after primary completion.
Of 69 industry-sponsored phase 1/2 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 103. This study's 61 months is close to that.
Counting every sponsor, half of 135 studies reached it within 72 months; a quarter within 50 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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