eligibility_summary
Eligible adults (≥18) with ECOG 0–1 and confirmed pancreatic ductal adenocarcinoma, must provide informed consent/HIPAA. Women of childbearing potential: abstain or use 2 effective contraception methods through 6 months post-treatment. Men with female partners: vasectomy or double barrier through 3 months post-infusion. Exclude those with interfering malignancies or unwilling/unable to comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single-arm study of an autologous gene‑modified cellular therapy: iC9.CAR.B7‑H3 T cells. These are patient-derived T lymphocytes engineered to express a chimeric antigen receptor that recognizes B7‑H3 (CD276), a B7 family immune-regulatory antigen frequently overexpressed on pancreatic ductal adenocarcinoma. Mechanism: CAR engagement of B7‑H3 activates the T cells to mediate cytotoxic killing of B7‑H3–positive tumor cells. The construct includes an inducible caspase‑9 (iC9) safety switch to allow rapid ablation of the CAR‑T cells if needed for toxicity control. Targets: B7‑H3/CD276 on PDAC cells, T‑cell activation and effector cytotoxic pathways.