All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the International Myeloma Foundation
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.
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.
P-BCMA-101 granted orphan drug designation in relapsed/refractory multiple myeloma
The U.S. Food and Drug Administration has granted P-BCMA-101 orphan drug designation in relapsed/refractory multiple myeloma (RRMM).
FDA Regenerative Medicine Advanced Therapy designation for P-BCMA CAR T-cell therapy
The US FDA has granted the P-BCMA-101 CAR T-cell therapy the Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of relapsed/refractory...
Subscribe to get the best content related to multiple myeloma delivered to your inbox