Definition

A preparation of autologous T cells that are enriched to be primarily stem memory T cells (Tscm) and are transfected by electroporation with a proprietary transposon-based DNA plasmid vector (PiggyBac), encoding both a chimeric antigen receptor (CAR) based on a proprietary non-immunoglobulin scaffold molecule Centyrin (CARTyrin), which specifically recognizes the tumor-associated antigen (TAA) prostate-specific membrane antigen (PSMA), and a human-derived safety switch that can be activated by rimiducid, with potential immunostimulating and antineoplastic activities. Upon administration, autologous anti-PSMA CAR T cells P-PSMA-101 specifically recognize and induce selective toxicity in PSMA-expressing tumor cells. Use of CARTyrin may elicit less immunotoxicity than CAR T cells based on antibody-derived single chain variable fragments (scFv), and may allow for increased persistence and decreased exhaustion for the administered T cells. If significant side effects occur, the safety switch mechanism can be activated by the administration of rimiducid, which results in the rapid attenuation or elimination of P-PSMA-101. PSMA is overexpressed on the surface of metastatic and hormone-refractory prostate cancer cells.