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

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.