eligibility_summary
Eligible: men 18–75 with metastatic castration‑resistant prostate adenocarcinoma, PSMA‑positive by IHC, ECOG 0–1, >6‑mo life expectancy, prior standard CRPC therapy with progression, negative HAV/HBV/HCV/HIV/TP NAAT, adequate counts (Hb>100 g/L, Plt>100×10^9/L, ANC>1.5×10^9/L). Exclude: prior CAR‑T/PSMA therapy, non‑adenocarcinoma, other active malignancy (unless cured/≥5y CR), severe mental/CV disease, active infection, abnormal liver/cardiac/coag labs, trials ≤3 mo or gene therapy, cyclophosphamide/fludarabine allergy, or investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06228404 tests an enhanced autologous PSMA CAR-T cell therapy for refractory castration‑resistant prostate cancer. Intervention: autologous chimeric antigen receptor T cells engineered via non‑viral transposon electroporation to integrate a PSMA‑targeting CAR, the CAR vector co‑expresses “enhanced factors” intended to strengthen innate and adaptive immune responses. Lymphodepleting preconditioning uses cyclophosphamide (alkylating agent) and fludarabine (purine analog) to reduce host lymphocytes and support CAR‑T expansion. Mechanism: CAR‑redirected T cells recognize PSMA on tumor cells and mediate cytotoxicity via CAR signaling and cytokine release, co‑expressed factors aim to augment immune activation. Targets: PSMA‑positive prostate cancer cells and immune activation pathways in T cells (with adjunct lymphodepletion).