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RECRUITING
NCT07284433
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

OTHER

Cyclophosphamide (Non-IMP, Lymphodepletion)

Intravenous infusion over 3 days (d-5 to d-3)

OTHER

Fludarabine (Non-IMP, Lymphodepletion)

Intravenous infusion over 3 days (d-5 to d-3)

DRUG

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