eligibility_summary
Adults (≥18) with advanced/metastatic/recurrent GI cancers (esp. colorectal, esophageal, gastric, pancreatic) after ≥2nd-line failure, CEA+ tumor (IHC ≥10%) and serum CEA >10 µg/L, measurable disease, ECOG 0–2, adequate organ function, eligible for apheresis, contraception, consent. Exclude CNS/leptomeningeal mets, recent trials/vaccines/therapy, active infection/GI bleed/obstruction, unresolved tox, major heart disease, autoimmune/immunosuppression, other recent cancers, active HBV/HCV/HIV/syphilis, pregnancy, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, open-label, dose-escalation trial testing CEA-targeted CAR-T cells (autologous, genetically engineered T-cell therapy) in adults with CEA-positive advanced/metastatic solid tumors. Two experimental arms: intravenous or intraperitoneal infusion (1–10×10^6 cells/kg) after lymphodepletion with fludarabine and cyclophosphamide. Mechanism: CAR-T cells express a chimeric antigen receptor that binds carcinoembryonic antigen (CEA) on tumor cells, triggering T-cell activation and cytotoxic killing, lymphodepletion promotes CAR-T expansion and persistence. Targets: CEA-expressing tumor cells (common in colorectal, gastric, esophageal, pancreatic, cholangiocarcinoma, lung, and breast cancers) and T-cell effector pathways. Primary aim: safety, MTD, and RP2D.