eligibility_summary
Consent, adults ≥18 with mCRPC, castrate T <50 ng/dL, prior therapy (ARSI or taxane), ECOG 0–1, adequate organ/hematologic function (LVEF ≥45%, O2 >92%, Hb ≥8, ANC ≥1000, Plt ≥75k). Continue GnRH if no orchiectomy, contraception required. Excl: active HBV/HCV/infection, NYHA III–IV, severe comorbidity, other invasive cancer <2y, chronic ≥10 mg prednisone, prior autologous T‑cell therapy (except sipuleucel‑T) or allo SCT, active autoimmune/MS, allergy to HSA/DMSO/Dextran 40.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: TmPSMA-02, an autologous, lentiviral-transduced CAR T-cell therapy for mCRPC. The CAR uses a humanized J591-derived anti-PSMA scFv and a CD2 costimulatory domain, it is dually armored with a dominant-negative TGFβ receptor (TGFβRDN) to block TGF-β–mediated suppression and a PD1.CD28 switch receptor that converts PD-1 inhibitory signals into CD28 costimulation, boosting activation, persistence, and function in the tumor microenvironment. Preconditioning: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Targets/pathways: PSMA+ prostate cancer cells, TGF-β signaling, PD-1/PD-L1 checkpoint, T-cell activation/costimulation (CD2/CD28), lymphodepletion to support CAR T expansion.