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

Study 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.

Interventions

Study Locations

Facility	City	State	Country
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

Official Trial Information

View on ClinicalTrials.gov