November 2, 2020 -- The U.S. Food and Drug Administration (FDA) has lifted a clinical trial hold on Poseida Therapeutics' phase I study of P-PSMA-101, an autologous chimeric antigen receptor (CAR) T-cell therapeutic candidate, for treatment of metastatic castration-resistant prostate cancer (mCRPC).
The company plans to resume the trial immediately, which initially began in May. The trial is an open label, multicenter, dose-escalating study that includes cohorts receiving single or multiple doses of P-PSMA-101, with the goal of determining the best dose with the fewest side effects.
The trial was paused by the FDA while a patient death was investigated per the study protocol. Poseida has agreed to implement protocol amendments to increase patient compliance and safety, including modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.
P-PSMA-101 is an autologous CAR T therapeutic candidate designed to target prostate-specific membrane antigen expressed on mCRPC cells. It was developed using the company's piggyBac DNA modification system, which produces product candidates with a high percentage of stem cell memory T cells.