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P-PSMA-101 is an autologous chimeric antigen receptor T cell (CAR-T) therapy designed to target prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells. The therapy is manufactured from a patient's own T cells using a novel non-viral transposon system (piggyBac), resulting in a product with a high percentage of stem cell memory T cells, which are associated with improved efficacy, safety, and bone homing—features particularly relevant for metastatic castration-resistant prostate cancer (mCRPC). The engineered CAR includes genes encoding for PSMA-targeted Centyrin CAR, an inducible caspase 9-based safety switch, and dihydrofolate reductase for purification. Upon administration, these modified T cells specifically recognize and induce selective toxicity in PSMA-expressing tumor cells. Preclinical studies demonstrated complete elimination of tumors in murine models of prostate cancer. Clinical trials have shown durable responses and favorable safety profiles in heavily pretreated mCRPC patients[1][2][3][4][5][6][8].
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