Poseida: FDA Clears IND Application Of P-BCMA-ALLO1 On Relapsed/Refractory Multiple Myeloma

(RTTNews) - Poseida Therapeutics Inc. (PSTX) said that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for P-BCMA-ALLO1, the company's first fully allogeneic CAR-T product candidate for patients with relapsed/refractory multiple myeloma.

The company noted that it is actively focused on opening clinical sites with the intention to begin dosing later this year.

P-BCMA-ALLO1-101 is a Phase 1 study comprised of open-label, dose escalation, multiple cohorts of allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory multiple myeloma.

The Phase 1 study follows a 3+3 design of dose-escalating cohorts. After a subject enrolls, allogeneic CAR-T cells will be administered as a single dose, following a standard chemotherapy-based conditioning regimen.