A Phase 1/2 interventional study of Cyclophosphamide (Non-IMP, Lymphodepletion) and Fludarabine (Non-IMP, Lymphodepletion) in Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma and Leukemia Relapse, sponsored by AvenCell Therapeutics, Inc.. Recruiting at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by AvenCell Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
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Among 108 studies in Lymphoma, Large B-Cell, Diffuse with a site in Germany — 15 open to participants now, 28 under way, 7 of them phase 3. Lymphoma, Large B-Cell, Diffuse · Germany.
Among the 108 studies in Lymphoma, Large B-Cell, Diffuse with a site in Germany, this one is the 47th largest by planned enrollment of the 100 interventional ones that give a count, is one of 4 that started in 2026, is one of 16 in phase 1/2, reaches primary completion later than 21 of the 27 other live ones, and was the 107th registered.
1,869 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 356 are open to participants now.
Browse Lymphoma, Large B-Cell, Diffuse studies →15 of the 108 studies in Lymphoma, Large B-Cell, Diffuse with a site in Germany are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Germany, United States, Australia and 9 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in Germany, United States, Argentina and 13 more countries
Ages 18+
Eli Lilly and Company · Sites in Germany, United States, France and 5 more countries
Ages 18+
Universität Münster · Sites in Germany
Ages 18+
Merck Sharp & Dohme LLC · Sites in Germany, United States, Belgium and 6 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 265 Lymphoma, Large B-Cell, Diffuse studies recruiting now, 177 (67%) set no upper age limit and 50 (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.
108 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 35 · Phase 2 47 · Phase 3 32 · Phase 4 1
First in 1994; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 178 is above the median of 45 across 1,498 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Median enrollment 156 across the 100 interventional studies, 595 across the 7 observational. Of the 78 that completed or were terminated, 39 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 108 have an industry lead sponsor. The 10 most frequent:
AvenCell Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
AvenCell Therapeutics, Inc. has 1 study filed under Lymphoma, Large B-Cell, Diffuse — fewer than ten, so there is no comparison to draw.
8 of the studies in Lymphoma, Large B-Cell, Diffuse with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| 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 |
| NCT02227251Karyopharm Therapeutics IncSelinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | 2026-12 |
| NCT03676504University Hospital HeidelbergTreatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR | 2026-12-31 |
| NCT05006716BeOne MedicinesA Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies | 2027-03 |
Add all 8 to your calendar (.ics) → With an account.
Among the 108 studies in Lymphoma, Large B-Cell, Diffuse with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is testing Allo-QuadCAR01-T, a new off-the-shelf CAR-T therapy for people with hard-to-treat B-cell cancers. Unlike current CAR-T treatments that use a patient's own cells, this therapy uses donor cells that are ready to use, which can save time and reduce costs. It targets two proteins, CD19 and CD20, to lower the chance of relapse and uses gene editing to make it safer. The trial has three parts: first to find a safe dose, then to confirm it, and finally to test how well it works in patients with diffuse large B-cell lymphoma (DLBCL). Patients will get one infusion after chemotherapy to prepare their body. The main goal is to check safety and see how many patients have a complete response by Week 13. About 160 patients will take part, and researchers will follow them for up to 15 years.
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.
Exclusion Criteria:
Other that may interfere with trial, except:
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 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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
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.
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.
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.
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.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
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.
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.
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.
Phase Ia (Escalation): Participants with relapsed or refractory B-cell malignancies will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T. Phase Ib (Expansion): After dose escalation, additional participants with relapsed or refractory B-cell lymphoma will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T at one or more tolerable dose levels from Phase Ia. Phase II: Participants with relapsed or refractory DLBCL will receive lymphodepleting chemotherapy, followed by a single infusion of Allo-QuadCAR01-T at the recommended Phase II dose. The primary endpoint is complete response rate at Week 13, with secondary endpoints including duration of response, progression-free survival, and overall survival.
Other: Cyclophosphamide (Non-IMP, Lymphodepletion) · Other: Fludarabine (Non-IMP, Lymphodepletion) · Drug: Allo-QuadCAR01-T
Intravenous infusion over 3 days (d-5 to d-3)
Intravenous infusion over 3 days (d-5 to d-3)
Single dose IV infusion on Day 1
Incidence of AEs defined as DLTs
Incidence and intensity of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for cytokine release syndrome (CRS), immune effector cell associated neurotoxicity syndrome (ICANS), tumor lysis syndrome, and graft versus host disease (GvHD), which will be graded according to widely accepted specialized criteria
Time frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
To determine the maximum tolerated dose (MTD)
MTD
Time frame: At the End of Cycle 1 (in total 28 days, given no treatment interruptions)
To determine the incidence of dose-limiting toxicities (DLT)
Incidence of DLTs
Time frame: At the end of cycle 1 (in total 28 days, given no treatment interruptions)
Phase 2: Complete response rate (CRR)
Complete remission rate is defined as the proportion of participants with complete remission, per international working group (IWG) Lugano classification, as assessed by the investigator.
Time frame: Up to week 13
Pharmacokinetics of Allo-QuadCAR01-T in PB in patients after infusion of Allo-QuadCAR01-T
Detection of VCN in blood samples
Time frame: Up to 24 months
To investigate the impact of Allo-QuadCAR01-T on MRD
MRD levels in responding CLL patients
Time frame: Up to 24 months
To evaluate immunogenicity against Allo-QuadCAR01-T
Incidence of ADA1 formation against anti-CD19/CD20 ECD and ADA2 formation against the RevCAR ECD of Allo-QuadCAR01-T
Time frame: Up to 24 months
To evaluate host immune cell depletion and reconstitution resulting from LD
Enumeration of host PB B-cell, T cell, and NK cell numbers
Time frame: Up to 24 months
Overall Response Rate (ORR)
ORR is defined as the proportion of participants with best objective response of either a CR or a partial response (PR) during the trial prior to any new anti-lymphoma, anti-CLL therapy or local radiotherapy for lymphoma , per the Lugano Classification, as determined by the investigator.
Time frame: Up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from Allo-QuadCAR01-T infusion to disease progression per the Lugano Classification, as determined by investigator review or death from any cause.
Time frame: Up to 24 months
Duration of Response (DOR)
DOR is defined as the time from first objective response to disease progression or death from any cause among participants who have achieved CR or PR per the Lugano Classification, as determined by the investigator.
Time frame: Up to 24 months
Overall Survival (OS)
OS is defined as the time from Allo-QuadCAR01-T infusion to death from any cause.
Time frame: Up to 24 months
Time to Next Treatment (TTNT)
TTNT is defined as time from Allo-QuadCAR01-T infusion to the start of subsequent new anti-lymphoma, anti-CLL therapy or local radiotherapy for lymphoma.
Time frame: Up to 24 months
Started Jan 2026 (actual). Primary completion is estimated for Apr 2029, 39 months after the start.
Of 51 industry-sponsored phase 1/2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 99. This study's planned 39 months is below that.
Counting every sponsor, half of 108 studies reached it within 70 months; a quarter within 50 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Lymphoma, Large B-Cell, Diffuse →
AvenCell Therapeutics, Inc.