eligibility_summary
Adults (≥18) with advanced/metastatic or recurrent tumors (mainly colorectal, esophageal, gastric, pancreatic) after ≥2 prior therapies or no options, CEA+ by IHC ≥10% (within 3 mo) and serum CEA >10 μg/L, measurable disease (RECIST 1.1), ECOG 0–2, adequate blood/organ/cardiac/respiratory function, apheresis eligible, contraception and consent. Exclude CNS mets, recent studies/live vaccine/therapy, active infection, GI obstruction/bleed, unresolved tox, major heart disease, autoimmune/immunosuppression, other cancer, HBV/HCV viremia, HIV/syphilis+, pregnancy, or other concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CEA-targeted CAR-T cells (autologous chimeric antigen receptor T lymphocytes) administered by intravenous or intraperitoneal infusion after lymphodepleting chemotherapy with fludarabine (purine antimetabolite) and cyclophosphamide (alkylating agent). Mechanism: CAR with anti-CEA scFv redirects T cells to CEA-positive tumor cells, inducing MHC-independent T-cell activation, expansion, cytokine release, and cytotoxic killing via perforin/granzyme. Dosing: 1–10×10^6 cells/kg in phase 1/2 dose-escalation/expansion. Targets: CEA-expressing malignant epithelial cells in colorectal, gastric, esophageal, pancreatic, lung, and breast cancers, key pathways include T-cell activation and effector cytotoxic pathways.