82% ORR in Heavily Pretreated RRMM: Roche/Poseida's Non-Viral Allogeneic CAR-T Therapy P-BCMA-ALLO1 Shows Promising Phase 1 Results

▎WuXi

Edited by Kant Content Team

Poseida Therapeutics Announces Positive Early Efficacy and Safety Results from Phase 1 Clinical Trial of Investigational Allogeneic CAR-T Therapy P-BCMA-ALLO1, Co-Developed with Roche, for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM) Patients.

In the trial, evaluable patients (n=33) had a follow-up period of at least 4 weeks and had all received extensive prior treatment, with a median of 7 prior treatment lines. The analysis showed,In patients who received intensive pre-treatment with adequate lymphocyte depletion, the objective response rate (ORR) of those treated with CAR-T therapy P-BCMA-ALLO1 was 82% (n=9/11), demonstrating deep clinical remission. In contrast, patients who had not previously received...B-Cell Maturation Antigen (BCMA)The ORR for patients treated with bispecific T-cell engager antibodies was 100%.

The therapy demonstrated good safety and reliability characteristics. No graft-versus-host disease (GvHD) or dose-limiting toxicity was observed in all intention-to-treat (ITT) patients, and the incidence of cytokine release syndrome (CRS) and neurotoxicity was low (both ≤ grade 2).

Notably, the study found,The expansion and persistence of CAR-T cells in patients after infusion are highly dependent on the pre-treatment dose of cyclophosphamide., when receiving 500mg/m

2 and 1000mg/m

2 The level of P-BCMA-ALLO1 measured in the blood of the patient cohorts in the P1 and P2 pre-treatment dose groups was significantly higher than that in patients receiving 300 mg/m

2-dose cohort (Cohort "S", n=20). The clinical response of patients in Cohort S was also inferior to that of patients in groups P1 or P2.

P-BCMA-ALLO1 is a BCMA-targeted allogeneic, stem cell memory-rich T-cell (T

SCM's "off-the-shelf" CAR-T therapy under research

, which is developed through a DNA modification system called piggyBac. Unlike most CAR-T therapies that are based on viral vectors, the piggyBac system can deliver the transgene expressing CAR into T cells without using viruses, and the vector can carry more genetic material. This is expected to lead to CAR-T therapies with lower costs, shorter production times, and avoidance of potential safety risks. In August 2022, Poseida Therapeutics reached a strategic collaboration and licensing agreement with Roche.

, will collaborate to develop off-the-shelf allogeneic CAR-T therapies, including P-BCMA-ALLO1.

[1] Poseida Therapeutics Presents Positive EarlyResults from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 inRelapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology(ASH) Annual Meeting. Retrieved December 11, 2023 from https://investors.poseida.com/news-releases/news-release-details/poseida-therapeutics-presents-positive-early-results-its-phase-1

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