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OncoMatch/Clinical Trials/NCT07284433

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

Is NCT07284433 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Allo-QuadCAR01-T for lymphoma diffuse large b-cell.

Phase 1/2RecruitingAvenCell Therapeutics, Inc.NCT07284433Data as of May 2026

Treatment: Allo-QuadCAR01-TThis 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Cannot have received: CAR-T cell therapy

Exception: CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T

Prior CAR-T within 3 months of screening, or ≥Grade 3 ICAHT from prior CAR-T

Cannot have received: autologous stem cell transplant

Exception: within 3 months

Autologous stem cell transplant within 3 months

Cannot have received: allogeneic stem cell transplant

Prior allogeneic stem cell transplant

Cannot have received: solid organ transplant

Prior solid organ transplant

Cannot have received: dual CD19/CD20 CAR-T

Prior therapy with dual CD19/CD20 CAR-T

Lab requirements

Kidney function

Liver function

Cardiac function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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