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

Recruiting now · Phase 1/Phase 2

Conditions studied: Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse, Lymphoma Receiving CAR-T Therapy

In brief

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.

Key facts

Study ID

NCT07284433

Run by

AvenCell Therapeutics, Inc.

People needed

178

Starts

2026-01-06

Expected to finish

2029-11-02

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Universitätsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany (enrolling)
• Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (enrolling)
• Universitätsklinikum Dresden — Dresden, Saxony, Germany (enrolling)
• Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Universitätsklinikum Marburg — Marburg, Hesse, Germany
• Uniklinikum Erlangen — Essen, North Rhine-Westphalia, Germany
• University of Chicago — Chicago, Illinois, United States
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Northwestern University — Evanston, Illinois, United States
• Brown University Health — Providence, Rhode Island, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Klinikum der Universität München — Munich, Bavaria, Germany

Full record on ClinicalTrials.gov

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