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Study of Allo-QuadCAR01-T for Relapsed or Refractory B-Cell Malignancies

This study is testing a new treatment called Allo-QuadCAR01-T for people with B-cell cancers like lymphoma or leukemia that have come back or haven't responded to other treatments. This therapy uses donor cells (allogeneic) that are ready to use, unlike treatments that use your own cells. Allo-QuadCAR01-T targets two proteins, CD19 and CD20, to make it more effective and safer. You would receive chemotherapy (Cyclophosphamide and Fludarabine) followed by a single infusion of Allo-QuadCAR01-T. The main goals are to find a safe dose and see how many patients have a complete response by Week 13. You may be able to join if you are an adult with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia, have had at least two prior treatments, and meet other health requirements.

Study design
This is an interventional study planning to enroll 178 participants. It aims to first find a safe dose, then confirm it, and finally test how well the treatment works.
What's involved
You would receive chemotherapy over three days, followed by a single intravenous infusion of Allo-QuadCAR01-T. The study will assess safety at the end of cycle 1 (28 days).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and dose determination are measured at the end of Cycle 1 (28 days). The study also aims to see how many patients have a complete response by Week 13.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07284433

Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
AvenCell Therapeutics, Inc.
~178 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Cyclophosphamide (Non-IMP, Lymphodepletion)Fludarabine (Non-IMP, Lymphodepletion)Allo-QuadCAR01-T

At a glance

Recruiting sites
6 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of AEs defined as DLTs
Measured over At the end of cycle 1 (in total 28 days, given no treatment interruptions)
+3 more outcomes measured

Conditions

Lymphoma Diffuse Large B-cell
Leukemia and Lymphoma
Leukemia Relapse
Lymphoma Receiving CAR-T Therapy

Explore related trials

B-Cell Non-Hodgkin LymphomaChronic Lymphocytic LeukemiaHLA Complex

Where it's being run

13 sites across 10 states
Illinois2
Bavaria2
Germany2
Rhode Island1
Tennessee1
Texas1
Baden-Wurttemberg1
Hesse1

Who to contact

Antje Warth, Dr.
[email protected]
0493514466450 · ext. 0
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults 18 years or older.
Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
Must have received at least 2 prior lines of therapy.
ECOG performance status 0-1 (able to carry out daily activities).
Adequate organ function (heart, liver, kidneys).
HLA B/C match with donor cells.
No active uncontrolled infections.

Exclusion

Active CNS involvement (including PCNSL) in dose escalation cohorts; may be allowed in later cohorts with Sponsor approval.
Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T.
Autologous stem cell transplant within 3 months.
Prior allogeneic stem cell transplant or solid organ transplant.
Prior therapy with dual CD19/CD20 CAR-T.
Severe hypersensitivity to trial agents or similar compounds.
History of GvHD or post-transplant lymphoproliferative disorder.
Presence of La/SS-B autoantibodies or related autoimmune diseases.
Other malignancy that may interfere with trial, except:
Curatively treated basal/squamous skin cancer or cervical carcinoma in situ
Low-grade, early-stage prostate cancer (Gleason ≤6, Stage 1-2) with no therapy needed
Adjuvant endocrine therapy for non-metastatic breast cancer (≥2 years)
Any other curatively treated malignancy in remission ≥2 years
Active viral infection within 1 week of screening, or serious bacterial/fungal infection.
Hemorrhagic cystitis.
Active neuro-autoimmune disease (e.g., MS, Guillain-Barré, ALS).
Active or residual HBV, HCV, or syphilis.
Active HIV. History of HIV may be eligible with Sponsor approval if:
Neurological disorders within 6 months (e.g., stroke, dementia, Parkinson's, cerebellar disease, CNS autoimmune disease).
Significant cardiac disease within 6 months (e.g., MI, stent, unstable angina).
Primary immunodeficiency or autoimmune disease requiring systemic treatment within 1 year (unless stable and Sponsor-approved).
Unresolved ≥Grade 2 non-hematologic toxicity from prior therapy (except neuropathy up to Grade 2).
Systemic immunosuppression within 28 days.
Last systemic lymphoma/CLL therapy (standard or investigational) within 28 days or 5 half-lives.
Major surgery within 14 days.
Local radiation within 28 days.
Live vaccination within 28 days.
Pregnant or breastfeeding.

What this trial measures

  • Incidence of AEs defined as DLTsAt the end of cycle 1 (in total 28 days, given no treatment interruptions)

    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

  • To determine the maximum tolerated dose (MTD)At the End of Cycle 1 (in total 28 days, given no treatment interruptions)

    MTD

  • To determine the incidence of dose-limiting toxicities (DLT)At the end of cycle 1 (in total 28 days, given no treatment interruptions)

    Incidence of DLTs

  • Phase 2: Complete response rate (CRR)Up to week 13

    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.