eligibility_summary
Inclusion: consent, histologic prostate cancer with PSMA expression, ECOG 0–2, SpO2>90%, adequate liver (ALT/AST<3×ULN, bilirubin/alk phos<2×ULN), renal (creatinine<2.0 mg/dL), cardiac (LVEF≥50%), hemoglobin≥80 g/L, recovered from prior therapy (chemo ≥7 days, immunotherapy ≥3 half-lives). Exclusion: other malignancy/major disease, active infection (HBV/HCV/HIV), immunosuppressants/systemic steroids, serious heart/cerebrovascular disease, immune/marrow deficiency, active/severe autoimmune disease, conditions raising CRS/CAR neurotox risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous PSMA-specific CAR-T cells (CART-PSMA), a gene-modified cellular immunotherapy. Mechanism: patient T cells are engineered to express a chimeric antigen receptor that binds prostate-specific membrane antigen (PSMA) on tumor cells, CAR engagement triggers T-cell activation, cytokine release, and cytotoxic killing of PSMA-positive prostate cancer cells. Dosing: single infusion at 1–3×10^7 or 1–3×10^8 cells/m^2, with or without lymphodepletion. Lymphodepletion regimen: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) for 3 days to deplete host lymphocytes and enhance CAR-T expansion. Targets: PSMA-expressing prostate tumor cells, immune pathways involved in CAR-mediated T-cell activation, expansion, and tumor cell lysis. Type of drugs: cellular therapy (CAR-T) plus cytotoxic chemotherapy for conditioning.