A Phase 1/2 interventional study of Chimeric Antigen Receptor T-Cell Therapy and Cyclophosphamide in Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Chronic Lymphocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by Fred Hutchinson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Treatment
The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).
OUTLINE:
This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy.
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide intravenously (IV). Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Patients will be actively participating in the study for approximately 15 months. The total time includes the time for the T cells to be made, the T cell infusion, and for approximately 12 months after the T cell infusion is given. After completion of study treatment, patients are followed up for a minimum of 15 years.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's enrollment of 53 is above the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Fred Hutchinson Cancer Center is the lead sponsor of 547 studies on the registry; 80 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
Compared within Lymphoma, Large B-Cell, Diffuse, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphoma, B-Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Patients must have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma. Eligible lymphoma subtypes include (but not limited to): mantle cell, follicular, lymphoplasmacytic, marginal zone, transformed indolent B cell lymphoma (including transformed chronic lymphoid leukemia [CLL]), or diffuse large B cell lymphoma that has after a response to at least one prior therapy regimen or is refractory to prior therapy; patients with mantle cell lymphoma must have previously been treated with a Bruton tyrosine kinase (BTK) inhibitor and have either had disease progression, intolerance, or exposure to the drug for at least 3 months; patients with CLL/SLL are eligible if they had disease progression or intolerance to BTKis and/or a BCL-2 inhibitors; they are also required to have been treated with the other agent for at least 3 months (i.e. patients with progression/intolerance to BTKi need to be treated with a BCL-2 inhibitor for at least 3 months, and patients with progression/intolerance to BCL-2 inhibitor need at least 3 months of exposure to a BTKi); patients with de novo diffuse large B-cell lymphoma (DLBCL) must meet one of the following criteria:
Relapsed or refractory disease after at least one of the following:
Patients with central nervous system (CNS) lymphoma need to meet one of the following criteria:
Primary CNS lymphoma:
Secondary CNS lymphoma:
Exclusion Criteria:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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 condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Biological: Chimeric Antigen Receptor T-Cell Therapy · Drug: Cyclophosphamide · Other: Laboratory Biomarker Analysis · Procedure: Leukapheresis · Drug: Fludarabine Phosphate
Drug page: Chimeric Antigen Receptor T-cells
Given CD20 CAR T cell IV
Also known as: CAR T-cell therapy, CAR T Infusion, CAR T Therapy
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Correlative studies
Undergo leukapheresis
Also known as: Leukocytopheresis, Therapeutic Leukopheresis
Given IV
Also known as: 2-F-ara-AMP, Beneflur, Fludara, Fludarabine-5''-Monophosphate, SH T 586
Dose-limiting Toxicities (DLT) Rate
Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
Time frame: Up to 28 days
Complete Remission
Will be assessed based on the Lugano criteria.
Time frame: Up to 15 years
Progression-free Survival (PFS)
A Cox proportional hazards model will be used to evaluate PFS.
Time frame: Duration from study enrollment to progression or death due to any cause (whichever comes first), assessed up to 15 years
Overall Survival (OS)
A Cox proportional hazards model will be used to evaluate OS.
Time frame: Duration from study enrollment to death due to any cause, assessed up to 15 years
Incidence of Adverse Events
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Time frame: Up to 15 years
| Milestone | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells |
|---|---|---|---|---|---|
| Started | 1 | 8 | 4 | 6 | 31 |
| Completed | 1 | 1 | 0 | 5 | 20 |
| Not completed | 0 | 7 | 4 | 1 | 11 |
Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
| participants | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells |
|---|---|---|---|---|---|
| Dose-limiting Toxicities (DLT) Rate | 0 | 0 | 0 | 0 | 0 |
Will be assessed based on the Lugano criteria.
Results for this outcome have not been posted.
A Cox proportional hazards model will be used to evaluate PFS.
Results for this outcome have not been posted.
A Cox proportional hazards model will be used to evaluate OS.
Results for this outcome have not been posted.
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Results for this outcome have not been posted.
Collected over Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 0 of CD20 CAR T Cells | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Dose Level 1 of CD20 CAR T Cells | 2/8 (25%) | 2/8 (25%) | 8/8 (100%) |
| Dose Level 2 of CD20 CAR T Cells | 3/4 (75%) | 1/4 (25%) | 4/4 (100%) |
| Dose Level 3 of CD20 CAR-T Cells | 3/6 (50%) | 2/6 (33.3%) | 6/6 (100%) |
| Dose Level 4 of CD20 CAR-T Cells | 7/31 (22.6%) | 18/31 (58.1%) | 31/31 (100%) |
| Event | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells |
|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/1 | 1/8 | 1/4 | 0/6 | 3/31 |
| Cytokine release syndromeImmune system disorders | 0/1 | 1/8 | 0/4 | 2/6 | 12/31 |
| PainGeneral disorders | 0/1 | 0/8 | 1/4 | 0/6 | 0/31 |
| Depressed level of consciousnessNervous system disorders | 0/1 | 0/8 | 0/4 | 1/6 | 0/31 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/1 | 0/8 | 0/4 | 1/6 | 0/31 |
| FeverGeneral disorders | 0/1 | 0/8 | 0/4 | 0/6 | 5/31 |
| Lung infectionInfections and infestations | 0/1 | 1/8 | 0/4 | 0/6 | 2/31 |
| Immune system disordersImmune system disorders | 0/1 | 0/8 | 0/4 | 0/6 | 2/31 |
| Abdominal painGastrointestinal disorders | 0/1 | 0/8 | 0/4 | 0/6 | 1/31 |
| General disorders and administration site conditions - Other, COVIDGeneral disorders | 0/1 | 0/8 | 0/4 | 0/6 | 1/31 |
| Event | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells |
|---|---|---|---|---|---|
| Lymphocyte count decreasedInvestigations | 1/1 | 8/8 | 4/4 | 6/6 | 28/31 |
| Neutrophil count decreasedInvestigations | 1/1 | 7/8 | 4/4 | 5/6 | 29/31 |
| White blood cell decreasedInvestigations | 1/1 | 8/8 | 4/4 | 5/6 | 28/31 |
| AnemiaBlood and lymphatic system disorders | 1/1 | 6/8 | 2/4 | 3/6 | 25/31 |
| HypotensionVascular disorders | 1/1 | 4/8 | 2/4 | 1/6 | 10/31 |
| AnorexiaMetabolism and nutrition disorders | 1/1 | 3/8 | 2/4 | 1/6 | 7/31 |
| HeadacheNervous system disorders | 1/1 | 2/8 | 2/4 | 2/6 | 7/31 |
| NauseaGastrointestinal disorders | 1/1 | 4/8 | 0/4 | 2/6 | 7/31 |
| Cytokine release syndromeImmune system disorders | 1/1 | 1/8 | 0/4 | 0/6 | 6/31 |
| FatigueGeneral disorders | 0/1 | 7/8 | 2/4 | 4/6 | 13/31 |
Patients enrolled and treated on study.
| Age, Continuous(years) | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells | Total |
|---|---|---|---|---|---|---|
| Mean | 43 ± 0 | 61 ± 9 | 61 ± 8 | 59 ± 9 | 67 ± 8 | 64 ± 9 |
| Sex: Female, Male(Participants) | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells | Total |
|---|---|---|---|---|---|---|
| Female | 1 | 2 | 1 | 2 | 13 | 19 |
| Male | 0 | 6 | 3 | 4 | 18 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 1 | 2 |
| Not Hispanic or Latino | 1 | 7 | 4 | 6 | 28 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 2 | 2 |
| Region of Enrollment(participants) | Dose Level 0 of CD20 CAR T Cells | Dose Level 1 of CD20 CAR T Cells | Dose Level 2 of CD20 CAR T Cells | Dose Level 3 of CD20 CAR-T Cells | Dose Level 4 of CD20 CAR-T Cells | Total |
|---|---|---|---|---|---|---|
| United States | 1 | 8 | 4 | 6 | 31 | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drugs tested here: Chimeric Antigen Receptor T-cells · Cyclophosphamide · Fludarabine phosphate
Lymphoma, Large B-Cell, Diffuse →
Fred Hutchinson Cancer Center →