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

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.

NCT Number	NCT07284433
Lead Sponsor	AvenCell Therapeutics, Inc. Collaborators: AvenCell Europe GmbH
Conditions	Lymphoma Diffuse Large B-cell, Leukemia and Lymphoma, Leukemia Relapse, Lymphoma Receiving CAR-T Therapy
Enrollment	178 participants
Start Date	2026-01-06
Primary Completion	2029-04-27 (estimated)
Study Completion	2029-11-02 (estimated)
Updated on ClinicalTrials.gov	2026-04-02