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Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
Sponsor: AvenCell Therapeutics, Inc.
Summary
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.
Official title: A Single-arm, Multicenter, Open-label, Phase I/II Trial of Allo-QuadCAR01-T, an Allogeneic CAR-T-cell Therapy Targeting CD19 and CD20, for the Treatment of Relapsed or Refractory B-cell Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2026-01-06
Completion Date
2029-11-02
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide (Non-IMP, Lymphodepletion)
Intravenous infusion over 3 days (d-5 to d-3)
Fludarabine (Non-IMP, Lymphodepletion)
Intravenous infusion over 3 days (d-5 to d-3)
Allo-QuadCAR01-T
Single dose IV infusion on Day 1
Locations (13)
University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Brown University Health
Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum der Universität München
Munich, Bavaria, Germany
Universitätsklinikum Marburg
Marburg, Hesse, Germany
Uniklinikum Erlangen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Dresden
Dresden, Saxony, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany