A Phase 1/2 interventional study of AUTO3 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Autolus Limited. Terminated at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Autolus Limited · Phase 1/2, Interventional, and Treatment
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Among 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States — 126 open to participants now, 218 under way, 18 of them phase 3. Lymphoma, Large B-Cell, Diffuse · United States.
Among the 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States, this one is the 351st largest by enrollment of the 963 interventional ones that give a count, is one of 42 that started in 2017, is one of 147 in phase 1/2, and was the 804th registered.
1,870 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 357 are open to participants now.
Browse Lymphoma, Large B-Cell, Diffuse studies →126 of the 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
Nathan Denlinger · Sites in United States
Ages 18+
Roswell Park Cancer Institute · Sites in United States
Ages 18+
University of Michigan Rogel Cancer Center · Sites in United States
Ages 18+
Weill Medical College of Cornell University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 266 Lymphoma, Large B-Cell, Diffuse studies recruiting now, 177 (67%) set no upper age limit and 51 (19%) stop at 75 or younger; 25 take children under 18; 7 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.
1,131 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 1 542 · Phase 2 537 · Phase 3 82 · Phase 4 2
First in 1988; this study’s year is marked. 42 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is above the median of 45 across 1,499 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Median enrollment 37 across the 963 interventional studies, 84 across the 66 observational. Of the 848 that completed or were terminated, 330 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
314 of 1,131 have an industry lead sponsor. The 10 most frequent:
Autolus Limited is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
Autolus Limited has 1 study filed under Lymphoma, Large B-Cell, Diffuse — fewer than ten, so there is no comparison to draw.
71 of the studies in Lymphoma, Large B-Cell, Diffuse with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04442022Phase 3Karyopharm Therapeutics IncA Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma | 2026-12 |
| NCT01804686Phase 3Janssen Research & Development, LLCA Long-term Extension Study of PCI-32765 (Ibrutinib) | 2026-12-31 |
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT04799275Phase 3National Cancer Institute (NCI)Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma | 2027-03-01 |
| NCT05578976Phase 3GenmabA Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) | 2027-06 |
Add all 71 to your calendar (.ics) → With an account.
Among the 1,131 studies in Lymphoma, Large B-Cell, Diffuse with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 with consolidation or pre-conditioning with anti-PD1 antibody in patients with DLBCL
The study will consist of 2 phases, a Phase I or dose escalation and expansion phase, and a Phase II. Patients with relapsed or refractory DLBCL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO3, a CD19 and CD22 dual targeting CAR T cell product. Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO 3 intravenously as a single dose and in addition a limited duration of treatment with an anti-PD1 antibody (either as part of the pre-conditioning regimen or consolidation). Patients will then enter a 36-month follow-up period.
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.
confirmed DLBCL and large B cell lymphoma subsets, including:
Phase I and Phase II Cohort 1:
Chemotherapy- disease, defined as one or more of the following:
OR
Relapse after ≥two or after ASCT. At a minimum:
For females of , a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment.
For females who are not or surgically sterile, highly effective methods of must be used during the treatment period and for at least 12 months after the last dose of study treatment.
Adequate renal, hepatic, pulmonary, and cardiac function defined as:
Patient has adequate bone marrow (BM) function without requiring ongoing blood product or granulocyte-colony stimulating factor support and meets the following criteria:
Exclusion Criteria:
Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
The following medications are excluded:
Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.
Phase I outpatient cohort:
For AUTO3 Infusion: Patients meeting any of the following exclusion criteria must not be treated with AUTO3 or have treatment delayed until they no longer meet these 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.
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.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
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 number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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).
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
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.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with relapsed or refractory DLBCL
Biological: AUTO3
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 900 x 10⁶ CD19/ CD22 Chimeric Antigen Receptor (CAR) positive T cells with limited duration of anti-PD1 antibody (pembrolizumab).
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
Phase I Escalation - Safety (Number of Participants With Grade 3-5 Toxicities) and Identification of Recommended Phase II Dose and Schedule (RP2D).
Number of patients with Grade 3-5 toxicities during escalation part of Phase I (Cohorts: 50x10\^6 CD19/22 CAR+ T Cells; 50x10\^6 CD19/22 CAR+ T Cells+Pembrolizumab \[Pem\] Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day -1 in Inpatient Setting) Dose-limiting toxicity defined as: * New non-hematological AE Grade \>=3 using NCI CTCAE (5.0), probably/definitely related to AUTO3, occurring in DLT evaluation period, which did not resolve to Grade 2 or better in 14 days, despite supportive measures. * Grade 4 CRS, neurotoxicity (NT), or cerebral edema, or Grade 3 NT that lasted \>72 hrs * Grade \>3 Disseminated Intravascular Coagulation * Grade \>2 Infusion Reaction with AUTO3 * Grade 4 or 5 event not managed with conventional supportive measures or necessitating dose reduction or modification to trial therapy * Any event that in opinion of Investigator and/or medical monitor put patient at undue risk could also have been considered DLT
Time frame: Within 75 days of AUTO3 infusion
Phase I Expansion - Safety (Incidence of Grade 3-5 Toxicities) in the Outpatient / Ambulatory Care Setting
The incidence of Grade 3-5 toxicities during the expansion part of Phase I (Dose cohort: 150 to 450 x 10\^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting)
Time frame: Within 75 days of AUTO3 infusion
Phase II - Overall Response Rate as Per Lugano Criteria
This was not analysed due to study termination prior to initiation of Phase II. End of study notification submitted to Medicines and Healthcare products Regulatory Agency (MHRA) (reference 46113/0003/001-0016) - The Last patient last visit was 19 October 2023 (at end of Phase 1) and the study is considered completed (End of study). As per protocol v10.0, end of study is defined as 36 months after the last patient has received AUTO3 infusion or earlier in the event of death or consent withdrawal. Fifty-two patients received AUTO3 in the Phase I part of the study. After reviewing the data and taking into consideration the available treatment landscape in r/r DLBCL, Autolus didn't progress AUTO3-DB1 into the Phase II part of the study. Autolus notified MHRA on 08 November 2021 about enrolment to Phase II of the study (Autolus has decided not to progress AUTO3-DB1 into the Phase II part of the study), and MHRA acknowledged it on 09 November 2021.
Time frame: Up to 2 years
Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis.
Feasibility of product generation was examined by assessing the number of AUTO3 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).
Time frame: Up to 8 weeks post leukapheresis.
Determine the Complete Response Rate Following Treatment With AUTO3, as Per Lugano Criteria.
Participants achieving objective response per Lugano criteria based on independent central radiology review. The Lugano classification of response by 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET-CT: 1. no uptake or no residual uptake (when used interim) 2. slight uptake, but below blood pool (mediastinum) 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease * complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass * partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size * stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion with an increase in intensity of FDG uptake from baseline (and/or
Time frame: Up to 2 years
Duration of Response (DOR).
Duration of response was defined as the time from the first observed complete response or partial response \[from the first post-baseline response assessment\] until the date of first progressive disease or death due to underlying cancer (primary reason for death=progressive disease), whichever occurred first. Only responders (patients with complete response \[CR\] or partial response \[PR\]) were included in the analysis of duration of response. Response defined by Lugano classification (see Outcome Measure 5). Patients with death not due to underling cancer (primary reason for death=adverse event \[AE\] or Other or Unknown) or who received new anti-cancer therapy other than SCT or discontinued from the study for other reason than progressive disease (PD) or who were lost to follow-up or reached the time point of analysis without a known record of progression or death had the duration of response censored at the date of last adequate disease assessment for response.
Time frame: Up to 2 years
Progression-free Survival (PFS).
The progression-free survival was defined as the time from first AUTO3 treatment until the first progression of disease or death from any cause, whichever occurred first. Patients who reached the time point of analysis without a known record of progression had the PFS censored at the date of last adequate disease assessment. Patients who received a new stem cell transplantation (SCT) were censored at the start date of this new SCT. Patients who received a new anti-cancer therapy or discontinued from the study for other reason than disease progression and who were lost to follow-up were censored at the date of last adequate disease assessment. Response defined by Lugano classification (see Outcome Measure 5).
Time frame: Up to 2 years
Overall Survival (OS).
Overall survival (OS) was defined as the time from the date of first AUTO3 treatment up to the date of death, regardless of cause of death. Patients alive at the time of the analysis had the OS censored at the date of last assessment when the patient was known alive.
Time frame: Up to 2 years
To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Maximum Concentration)
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
Time frame: Up to 2 years
To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Area Under the Curve From Day 0 to Day 28)
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
Time frame: Up to 2 years
To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Time to Maximum Concentration)
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
Time frame: Up to 2 years
| Milestone | 50 x 10^6 Cluster of Differentiation Antigen 19/22 (CD19/CD22) CAR+ T Cells | 50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Started | 4 | 3 | 8 | 17 | 20 |
| Completed | 0 | 1 | 3 | 3 | 4 |
| Not completed | 4 | 2 | 5 | 14 | 16 |
| Withdrew: Progressive disease | 4 | 2 | 3 | 10 | 8 |
| Withdrew: Death | 0 | 0 | 2 | 3 | 4 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 4 |
Number of patients with Grade 3-5 toxicities during escalation part of Phase I (Cohorts: 50x10\^6 CD19/22 CAR+ T Cells; 50x10\^6 CD19/22 CAR+ T Cells+Pembrolizumab \[Pem\] Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day 14; 150-450x10\^6 CD19/22 CAR+ T Cells+Pem Day -1 in Inpatient Setting) Dose-limiting toxicity defined as: * New non-hematological AE Grade \>=3 using NCI CTCAE (5.0), probably/definitely related to AUTO3, occurring in DLT evaluation period, which did not resolve to Grade 2 or better in 14 days, despite supportive measures. * Grade 4 CRS, neurotoxicity (NT), or cerebral edema, or Grade 3 NT that lasted \>72 hrs * Grade \>3 Disseminated Intravascular Coagulation * Grade \>2 Infusion Reaction with AUTO3 * Grade 4 or 5 event not managed with conventional supportive measures or necessitating dose reduction or modification to trial therapy * Any event that in opinion of Investigator and/or medical monitor put patient at undue risk could also have been considered DLT
| participants | 50 x 10^6 CD19/CD22 CAR+ T Cells | 50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Patients with Grade 3-5 toxicity | 4 | 3 | 7 | 13 | — |
| Patients with dose-limiting toxicity | 0 | 0 | 0 | 0 | — |
The incidence of Grade 3-5 toxicities during the expansion part of Phase I (Dose cohort: 150 to 450 x 10\^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting)
| Participants | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Phase I Expansion - Safety (Incidence of Grade 3-5 Toxicities) in the Outpatient / Ambulatory Care Setting | 0 | 0 | 0 | 0 | 13 |
This was not analysed due to study termination prior to initiation of Phase II. End of study notification submitted to Medicines and Healthcare products Regulatory Agency (MHRA) (reference 46113/0003/001-0016) - The Last patient last visit was 19 October 2023 (at end of Phase 1) and the study is considered completed (End of study). As per protocol v10.0, end of study is defined as 36 months after the last patient has received AUTO3 infusion or earlier in the event of death or consent withdrawal. Fifty-two patients received AUTO3 in the Phase I part of the study. After reviewing the data and taking into consideration the available treatment landscape in r/r DLBCL, Autolus didn't progress AUTO3-DB1 into the Phase II part of the study. Autolus notified MHRA on 08 November 2021 about enrolment to Phase II of the study (Autolus has decided not to progress AUTO3-DB1 into the Phase II part of the study), and MHRA acknowledged it on 09 November 2021.
No measurements were reported for this outcome.
Feasibility of product generation was examined by assessing the number of AUTO3 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).
| Participants | AUTO3 |
|---|---|
| Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis. | 52 |
Participants achieving objective response per Lugano criteria based on independent central radiology review. The Lugano classification of response by 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET-CT: 1. no uptake or no residual uptake (when used interim) 2. slight uptake, but below blood pool (mediastinum) 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease * complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass * partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size * stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion with an increase in intensity of FDG uptake from baseline (and/or
| Participants | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Determine the Complete Response Rate Following Treatment With AUTO3, as Per Lugano Criteria. | 1 | 1 | 4 | 8 | 8 |
Duration of response was defined as the time from the first observed complete response or partial response \[from the first post-baseline response assessment\] until the date of first progressive disease or death due to underlying cancer (primary reason for death=progressive disease), whichever occurred first. Only responders (patients with complete response \[CR\] or partial response \[PR\]) were included in the analysis of duration of response. Response defined by Lugano classification (see Outcome Measure 5). Patients with death not due to underling cancer (primary reason for death=adverse event \[AE\] or Other or Unknown) or who received new anti-cancer therapy other than SCT or discontinued from the study for other reason than progressive disease (PD) or who were lost to follow-up or reached the time point of analysis without a known record of progression or death had the duration of response censored at the date of last adequate disease assessment for response.
| months | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Duration of Response (DOR). | 6.31 (1.97 to NA) | NA (NA to NA) | NA (NA to NA) | 4.96 (1.91 to NA) | NA (NA to NA) |
The progression-free survival was defined as the time from first AUTO3 treatment until the first progression of disease or death from any cause, whichever occurred first. Patients who reached the time point of analysis without a known record of progression had the PFS censored at the date of last adequate disease assessment. Patients who received a new stem cell transplantation (SCT) were censored at the start date of this new SCT. Patients who received a new anti-cancer therapy or discontinued from the study for other reason than disease progression and who were lost to follow-up were censored at the date of last adequate disease assessment. Response defined by Lugano classification (see Outcome Measure 5).
| months | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Progression-free Survival (PFS). | 2.14 (0.76 to NA) | 2.43 (2.40 to NA) | 5.67 (0.95 to NA) | 3.22 (1.87 to NA) | 3.22 (1.94 to 5.88) |
Overall survival (OS) was defined as the time from the date of first AUTO3 treatment up to the date of death, regardless of cause of death. Patients alive at the time of the analysis had the OS censored at the date of last assessment when the patient was known alive.
| months | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| Overall Survival (OS). | 10.04 (0.95 to NA) | 6.67 (4.93 to NA) | 5.67 (1.77 to NA) | 9.17 (3.32 to NA) | NA (NA to NA) |
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
| copies/microgram DNA | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Maximum Concentration) | 7979.7 (155 to 213000) | 13157.4 (3900 to 47100) | 5726.1 (1420 to 11600) | 4121.4 (174 to 416000) | 3195.6 (241 to 131000) |
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
| day*copies/microgram DNA | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Area Under the Curve From Day 0 to Day 28) | 41511.0 (912 to 2370000) | 109945.2 (35600 to 478000) | 38397.9 (3510 to 135000) | 37722.7 (948 to 571000) | 32152.1 (1060 to 1930000) |
Analysis of cells in peripheral blood by polymerase chain reaction and/or flow cytometry at a range of time points in the peripheral blood.
| Days | 50 x 10^6 CD19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting |
|---|---|---|---|---|---|
| To Determine the Expansion and Persistence of AUTO3 Following Adoptive Transfer in Different Lymphoma Subtypes (Time to Maximum Concentration) | 16.4 (12 to 22) | 13.9 (11 to 14) | 9.7 (9 to 35) | 10.0 (7 to 28) | 13.1 (7 to 58) |
Collected over From AUTO3 infusion (Day -7) until end of study/patient withdrawal OR, when patient initiated a new treatment for their disease (approximately 3 years and 5 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 50 x 10^6 CD19/CD22 CAR+ T Cells | 3/4 (75%) | 2/4 (50%) | 4/4 (100%) |
| 50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 2/3 (66.7%) | 0/3 (0%) | 3/3 (100%) |
| 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 5/8 (62.5%) | 3/8 (37.5%) | 8/8 (100%) |
| 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 11/17 (64.7%) | 10/17 (58.8%) | 15/17 (88.2%) |
| 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | 6/20 (30%) | 14/20 (70%) | 19/20 (95%) |
| Treatment Not Received | 6/10 (60%) | 0/10 (0%) | 1/10 (10%) |
| Event | 50 x 10^6 CD19/CD22 CAR+ T Cells | 50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Treatment Not Received |
|---|---|---|---|---|---|---|
| PyrexiaGeneral disorders | 2/4 | 0/3 | 0/8 | 2/17 | 3/20 | 0/10 |
| AnaemiaBlood and lymphatic system disorders | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| Cytokine release syndromeImmune system disorders | 1/4 | 0/3 | 1/8 | 1/17 | 5/20 | 0/10 |
| Depressed level of consciousnessNervous system disorders | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| Facial paresisNervous system disorders | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| HeadacheNervous system disorders | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| HemiparesisNervous system disorders | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| NystagmusNervous system disorders | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| Radiation pneumonitisInjury, poisoning and procedural complications | 1/4 | 0/3 | 0/8 | 0/17 | 0/20 | 0/10 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/4 | 0/3 | 1/8 | 2/17 | 3/20 | 0/10 |
| Event | 50 x 10^6 CD19/CD22 CAR+ T Cells | 50 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR+ T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Treatment Not Received |
|---|---|---|---|---|---|---|
| Neutrophil count decreasedInvestigations | 4/4 | 3/3 | 3/8 | 3/17 | 2/20 | 0/10 |
| Platelet count decreasedInvestigations | 4/4 | 3/3 | 3/8 | 2/17 | 4/20 | 0/10 |
| AnaemiaBlood and lymphatic system disorders | 2/4 | 2/3 | 6/8 | 9/17 | 8/20 | 0/10 |
| ConstipationGastrointestinal disorders | 2/4 | 2/3 | 2/8 | 5/17 | 0/20 | 0/10 |
| PyrexiaGeneral disorders | 1/4 | 2/3 | 4/8 | 1/17 | 5/20 | 0/10 |
| NeutropeniaBlood and lymphatic system disorders | 2/4 | 0/3 | 4/8 | 9/17 | 5/20 | 0/10 |
| Abdominal painGastrointestinal disorders | 2/4 | 1/3 | 0/8 | 0/17 | 1/20 | 0/10 |
| Cytokine release syndromeImmune system disorders | 2/4 | 0/3 | 3/8 | 4/17 | 5/20 | 0/10 |
| FatigueGeneral disorders | 1/4 | 1/3 | 4/8 | 2/17 | 8/20 | 0/10 |
| HeadacheNervous system disorders | 2/4 | 0/3 | 0/8 | 5/17 | 2/20 | 0/10 |
Sixty-two patients were enrolled. Ten patients did not receive AUTO3 infusion, in 6 patients this was due to death, in 3 patients due to progressive disease (without death), and in 1 patient due to failed eligibility, leaving 52 participants.
| Age, Categorical(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 7 | 7 | 16 | 37 |
| >=65 years | 0 | 0 | 1 | 10 | 4 | 15 |
| Sex: Female, Male(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| Female | 2 | 3 | 7 | 7 | 16 | 35 |
| Male | 2 | 0 | 1 | 10 | 4 | 17 |
| Ethnicity (NIH/OMB)(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 5 | 6 |
| Not Hispanic or Latino | 4 | 3 | 8 | 16 | 9 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 6 | 6 |
| Race (NIH/OMB)(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 3 | 4 |
| White | 4 | 3 | 8 | 15 | 14 | 44 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 3 | 3 |
| Eastern Cooperative Oncology Group (ECOG) score(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| ECOG = 0 | 1 | 1 | 7 | 9 | 8 | 26 |
| ECOG = 1 | 3 | 2 | 1 | 8 | 12 | 26 |
| Disease stage(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| Stage II | 0 | 0 | 1 | 2 | 3 | 6 |
| Stage III | 0 | 2 | 2 | 3 | 4 | 11 |
| Stage IV | 4 | 1 | 5 | 12 | 13 | 35 |
| Relapsed/Refractory disease(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| Relapsed | 0 | 0 | 1 | 4 | 11 | 16 |
| Refractory | 0 | 1 | 2 | 6 | 3 | 12 |
| Relapsed and Refractory | 4 | 2 | 5 | 7 | 6 | 24 |
| Extranodal disease present(Participants) | 50 x 10^6 Cluster of Differentiation (CD) 19/CD22 CAR-positive T Cells | 50 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day 14 | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Inpatient Setting | 150 to 450 x 10^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting | Total |
|---|---|---|---|---|---|---|
| No | 2 | 2 | 3 | 6 | 7 | 20 |
| Yes | 2 | 1 | 5 | 11 | 13 | 32 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in Oct 2023, 73 months.
Results were first posted in Jul 2025, 1 year 8 months after primary completion.
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Lymphoma, Large B-Cell, Diffuse →
Autolus Limited