ALLO-501A (cemacabtagene ansegedleucel; cema-cel) is an investigational off-the-shelf, allogeneic anti-CD19 CAR T-cell therapy developed by Allogene Therapeutics for the treatment of relapsed or refractory large B-cell lymphoma and other relapsed/refractory non-Hodgkin lymphomas. It is manufactured from healthy donor T cells and engineered ex vivo using TALEN gene-editing technology to disrupt endogenous T-cell receptor expression and CD52, thereby reducing graft-versus-host disease risk and enabling selective lymphodepletion with the anti-CD52 monoclonal antibody ALLO-647. ALLO-501A is administered following lymphodepletion with fludarabine, cyclophosphamide, and ALLO-647 and is designed to provide immediate, off-the-shelf access to CD19-directed CAR T-cell therapy.
Disease: Large B-cell lymphoma, LBCL, (NCT06500273)
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Candidate summary:
Disease/Disease category:
- Haematological malignancies (blood cancers)
Official title:
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma (ALPHA3)
Phases:
- Phase 2
Status:
Active recruiting
Country:
- United States
- Canada
- South Korea
- Australia
