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P-BCMA-ALLO1 receives clearance of investigational new drug application by FDA for the treatment of multiple myeloma

Sep 3, 2021
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On August 30, 2021, it was announced that the U.S Food and Drug Administration (FDA) has cleared an Investigational New Drug application for P-BCMA-ALLO1 for the treatment of patients with relapsed/refractory multiple myeloma (RRMM).

P-BCMA-ALLO1 is a fully allogeneic chimeric antigen receptor T-cell product designed to target B-cell maturation antigen (BCMA). The agent demonstrated encouraging antitumor responses and cytokine secretion both in vivo and in vitro. The manufacturing protocol involves a ‘booster molecule’ that facilitates expansion, significantly increases product yield, and reduces cost.

This decision from the FDA permits patient enrollment to a phase I study (NCT04960579) evaluating P-BCMA-ALLO1 for the treatment of patients with RRMM following treatment with a proteasome inhibitor, immunomodulatory agent, and anti-CD38 therapy. The study will follow a 3×3 dose-escalation design, with patients first receiving chemotherapy-based conditioning and an initial single dose of the study drug. Once acceptable safety and tolerability has been confirmed, patients can continue with additional doses of P-BCMA-ALLO1. The study design grants the investigation of alternative dosing regimens and patient enrollment is set to commence in late 2021.

If successful in clinical trials, P-BCMA-ALLO1 could offer an effective, accessible, and cost-effective treatment approach to RRMM.

  1. Poseida Therapeutics. Poseida Therapeutics announces FDA clearance of investigational new drug application for P-BCMA-ALLO1, an allogeneic CAR-T candidate for relapsed/refractory multiple myeloma. https://investors.poseida.com/news-releases/news-release-details/poseida-therapeutics-announces-fda-clearance-investigational-new. Published Aug 30, 2021. Accessed Sept 1, 2021.

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