Study of Allo-QuadCAR01-T, an Allogeneic CAR-T Targeting CD19/CD20, in Patients With Relapsed or Refractory B-Cell Malignancies
Start Date
1/6/2026
Completion Date
11/2/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cyclophosphamide (Non-IMP, Lymphodepletion)
Fludarabine (Non-IMP, Lymphodepletion)
Allo-QuadCAR01-T
Conditions
Locations
University of Chicago
Chicago, Illinois 60637
United States
Northwestern University
Evanston, Illinois 60208
United States
Brown University Health
Providence, Rhode Island 02903
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg 89081
Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria 91054
Germany
Klinikum der Universität München
Munich, Bavaria 81377
Germany
Universitätsklinikum Marburg
Marburg, Hesse 35032
Germany
Uniklinikum Erlangen
Essen, North Rhine-Westphalia 45147
Germany
Universitätsklinikum Dresden
Dresden, Saxony 01307
Germany
Charité Universitätsmedizin Berlin
Berlin, 13353
Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany