FDA Clears IND Application for P-CD19CD20-ALLO1

The US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for P-CD19CD20-ALLO1, an allogeneic dual chimeric antigen receptor (CAR) T-cell therapy for B-cell malignancies.

The CAR-T targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies. It will be evaluated for safety, tolerability, and preliminary efficacy in a phase I multicenter, open-label, dose-escalation study, which will enroll up to 70 patients. After enrollment, patients will receive a chemotherapy-based lymphodepletion regimen followed by administration of the product.

Source: PR Newswire, July 2023