eligibility_summary
Adults (≥18) with advanced/metastatic/recurrent GI cancers (CRC, esophageal, gastric, pancreatic) after ≥2nd-line failure, CEA+ tumor (IHC ≥10%) and CEA >10 µg/L, measurable (RECIST 1.1), ECOG 0–2, adequate organ function, O2 ≥95%, apheresis-eligible, contraception, consent. Exclude CNS mets, recent trial/vaccine/tx, infection, obstruction/bleeding, large effusions, tox >G1, major cardiac disease, autoimmune/immunosuppression, other cancer, HBV/HCV/HIV/syphilis, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06126406 tests CEA-targeted CAR-T cells, a gene-modified autologous T‑cell therapy, given intravenously or intraperitoneally (≈1–10×10^6 cells/kg) after lymphodepleting chemotherapy (fludarabine + cyclophosphamide). Mechanism: patient T cells are engineered to express a chimeric antigen receptor that binds carcinoembryonic antigen (CEA/CEACAM5) on tumor cells, CAR engagement activates CD3ζ (± costimulatory domains), driving T‑cell activation, proliferation, cytokine release, and perforin/granzyme-mediated cytotoxicity to kill CEA+ cancer cells. Targets: CEA-expressing solid tumor cells (e.g., colorectal, gastric, esophageal, pancreatic, others). Pathways engaged: CAR signaling (TCR-independent), effector T‑cell cytotoxic pathways, and cytokine-mediated antitumor immunity, lymphodepletion enhances CAR‑T expansion and persistence. Phase 1 focuses on safety, PK, and dose finding.