The FDA has lifted the clinical hold on the phase 1 study of P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.
The FDA has lifted the clinical hold on the phase 1 study of P-PSMA-101 in patients with metastatic castration-resistant prostate cancer (mCRPC), according to Poseida Therapuetics, the developer of the agent.
Following this announcement, the company indicated it plans to resume the trial immediately. Of note, P-PSMA-101 is the company's first solid tumor autologous CAR-T therapeutic candidate.
The phase 1 trial of P-PSMA-101 in mCRPC was initiated in May 2020. Moving forward, Poseida has agreed to implement protocol amendments per the FDA’s guidance intended to increase patient compliance and safety that include modified inclusion and exclusion criteria and frequency of monitoring and laboratory testing.
P-PSMA-101 is designed to target prostate-specific membrane antigen (PSMA), which is expressed on mCRPC cells. The agent was developed using Poseida's proprietary piggyBac DNA Modification System, which produces product candidates with a high percentage of stem cell memory T-cells.
Poseida Therapeutics Announces Clinical Hold Lifted on Phase I Autologous CAR-T Study in Prostate Cancer [news release]. San Diego. Published November 2, 2020. Accessed November 2, 2020. https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-clinical-hold-lifted-on-phase-i-autologous-car-t-study-in-prostate-cancer-301164397.html