Hold Lifted on Phase 1 Trial Testing P-PSMA-101 CAR T-cell Therapy in mCRPC

Hold Lifted on Phase 1 Trial Testing P-PSMA-101 CAR T-cell Therapy in mCRPC
A Phase 1 trial evaluating Poseida Therapeutics’ autologous CAR T-cell therapy P-PSMA-101 for metastatic castration-resistant prostate cancer (mCRPC) is resuming immediately, after its clinical hold was lifted. The U.S. Food and Drug Administration (FDA) had placed a partial hold on the trial in August, after a patient died of liver failure a few weeks after receiving the therapy. Poseida will now implement changes to its protocol to enhance patient compliance and safety, including modified criteria for patient inclusion and exclusion in the trial, and more frequent monitoring, the company announced in a press release. P-PSMA-101 is a type of immunotherapy in which a patient's own T-cells — immune cells with anti-tumor activity — are collected and genetically modified in the lab to better fight cancer, and then are expanded and infused back into the patient. Specifically, P-PSMA-101 contains T-cells engineered to produce a man-made
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