eligibility_summary
Inclusion: Adults ≥18 with advanced CRC, esophageal/EGJ, gastric, pancreatic, NSCLC, breast or cholangiocarcinoma after standard therapy (CRC ≥3rd line, others ≥2nd, pancreas ≥1st), CEA+ (IHC 3+ or serum ≥2×ULN), measurable disease, ECOG 0–1 (pancreas 0–2), adequate organs, survival >12 wks, apheresis feasible, contraception/consent. Exclusion: prior CAR‑T/gene cells, high‑risk brain mets, recent trials/vaccines/PD‑1/chemo/steroids, active infection, serious GI/resp disease, uncontrolled effusions, serious cardiac, active autoimmune on IS, active HBV/HCV/HIV/syphilis/CMV, VTE on anticoag, other malignancy, pregnancy, unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm, dose-escalation study in China testing C-13-60, an autologous CEA-targeted CAR-T cell therapy for CEA-positive advanced solid tumors (colorectal, esophageal, gastric, pancreatic, NSCLC, breast, cholangiocarcinoma). Drug/intervention: CEA-targeted CAR-T cells (biologic, gene-modified T cells) given IV at 2–10×10^6 cells/kg, patients receive lymphodepleting chemotherapy with fludarabine (purine analog causing lymphocyte depletion) and cyclophosphamide (alkylating agent) before infusion to enhance CAR-T expansion. Mechanism: CAR-engineered T cells recognize carcinoembryonic antigen (CEA/CEACAM5) on tumor cells, triggering T-cell activation, cytokine release, and cytotoxic killing independent of native TCR. Targets: CEA-expressing epithelial tumor cells, immune effector pathway: CAR signaling in T cells, preconditioning targets host lymphocytes to support CAR-T engraftment.