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
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults 18 years or older.
• Diagnosed with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukemia (CLL).
• Must have received at least 2 prior lines of therapy.
• ECOG performance status 0-1 (able to carry out daily activities).
• Adequate organ function (heart, liver, kidneys).
• HLA B/C match with donor cells.
• No active uncontrolled infections.
Locations
United States
Illinois
University of Chicago
NOT_YET_RECRUITING
Chicago
Northwestern University
NOT_YET_RECRUITING
Evanston
Rhode Island
Brown University Health
NOT_YET_RECRUITING
Providence
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Other Locations
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsklinikum Dresden
RECRUITING
Dresden
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Uniklinikum Erlangen
NOT_YET_RECRUITING
Essen
Universitätsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Universitätsklinikum Marburg
NOT_YET_RECRUITING
Marburg
Klinikum der Universität München
NOT_YET_RECRUITING
Munich
Universitätsklinikum Ulm
RECRUITING
Ulm
Contact Information
Primary
Antje Warth, Dr.
avc-203-01@avencell.com
0493514466450
Backup
Markese Sanders
avc-203-01@avencell.com
617-941-7468
Time Frame
Start Date:2026-01-06
Estimated Completion Date:2029-11-02
Participants
Target number of participants:178
Treatments
Experimental: Allo-QuadCAR01-T
Phase Ia (Escalation): Participants with relapsed or refractory B-cell malignancies will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T.~Phase Ib (Expansion): After dose escalation, additional participants with relapsed or refractory B-cell lymphoma will receive lymphodepleting chemotherapy followed by a single infusion of Allo-QuadCAR01-T at one or more tolerable dose levels from Phase Ia.~Phase II: Participants with relapsed or refractory DLBCL will receive lymphodepleting chemotherapy, followed by a single infusion of Allo-QuadCAR01-T at the recommended Phase II dose. The primary endpoint is complete response rate at Week 13, with secondary endpoints including duration of response, progression-free survival, and overall survival.