QUADvance: Advancing Allo Quad-CAR01-T Therapy in Hard-to-Treat B-Cell Cancer
Research type
Research Study
Full 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
IRAS ID
1012290
Contact name
Tapan Maniar
Contact email
Sponsor organisation
AvenCell Therapeutics Inc.
Eudract number
2025-521735-36
Research summary
This research study is testing a new drug called “Allo-QuadCAR01-T” for the treatment of patients with blood cancers called B cell lymphomas. Allo-QuadCAR01-T is a type CAR-T cell treatment, which is a form of immunotherapy. That means it uses specially modified immune cells (T cells) to find and destroy cancer cells. Most CAR-T therapies are currently made using a patient’s own T cells, but Allo-QuadCAR01-T is allogeneic, where the CAR-T cells are made T cells donated from a healthy volunteer.
Allo-QuadCAR01-T is also different to currently available CAR T treatments because it targets two different proteins on the cancerous B cells (CD19 and CD20). We believe that this will increase the chances of finding and killing the B cells more effectively, which may lead to remission of the cancer.
This study is in 3 phases:
• Phase Ia: The first phase where safety and tolerability of different doses of the treatment are carefully tested (in 6-36 patients) to find the
most promising dose(s).
• Phase Ib: To confirm the best dose(s), where safety, tolerability and effectiveness of the drug are tested (in up to 60 patients)
• Phase II: To confirm the effectiveness, tolerability, and safety of the drug on the best dose identified in phase I; up to 100 patients will be treated in phase II.After this Phase, the drug may become available for wider use according to the results from the whole trial.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0212
Date of REC Opinion
29 Oct 2025
REC opinion
Further Information Unfavourable Opinion