eligibility_summary
Adults ≥18 with PSCA+ mCRPC, ECOG 0–2/KPS≥70, progressing on ≥1 AR‑targeted therapy. Adequate recovery/washouts, ANC≥1000, Plt≥100k, AST/ALT≤2.5×ULN, bili≤2.0, CrCl≥50, QTc≤480, normal ECG, consent and tumor tissue, infection screen negative or viral load undetectable, males use contraception. Plan 2: 1–3 radiatable lesions. Exclude: systemic steroids/immunosuppression, significant arrhythmia, CNS inflammatory disease/seizure, severe allergy, bleeding disorder, stroke/ICH <6 mo, other active malignancy, uncontrolled illness, active infection needing antibiotics, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05805371 (Phase 1b) in PSCA+ metastatic castration‑resistant prostate cancer. Interventions and mechanisms: 1) Autologous anti‑PSCA CAR‑T cells (biologic/cellular therapy, PSCA[dCH2]BBζ CAR) given IV after lymphodepletion, up to 3 cycles. CAR design uses a PSCA‑binding scFv to recognize tumor, a 4‑1BB (CD137) co‑stimulatory domain to enhance T‑cell persistence, a CD3ζ signaling domain for T‑cell activation/cytotoxicity, and a truncated CD19 (CD19t) tag for selection/tracking. 2) External beam radiation therapy (metastasis‑directed, 16 Gy in 2 fractions) in one arm, radiation directly kills tumor cells and may increase antigen release/immunogenicity. Targets: PSCA‑expressing prostate cancer cells, T‑cell activation pathways via 4‑1BB/CD3ζ within infused T lymphocytes, radiation targets tumor DNA in metastatic lesions. Preconditioning lymphodepletion reduces host lymphocytes to support CAR‑T expansion.