eligibility_summary
Adults (≥18) with advanced/metastatic/recurrent CEA‑positive solid tumors (colorectal, esophageal, gastric, pancreatic, lung, cholangiocarcinoma) after ≥2nd‑line failure/no options, measurable lesion, ECOG 0–2, adequate organ function (cardiac, renal, hepatic, marrow, O2), eligible for apheresis, contraception, consent. Exclude uncontrolled CNS mets, recent trials/vaccines/therapy, active infection/GI bleeding, unresolved toxicity, serious cardiac/autoimmune disease, active HBV/HCV/HIV/syphilis, pregnancy, other cancer <3y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06821048 is a Phase I, single-center, open-label, dose-escalation/expansion study testing PTC13, a CEA-targeted chimeric antigen receptor T-cell therapy (CAR-T, autologous cellular immunotherapy) delivered by intraperitoneal infusion for CEA-positive advanced solid tumors (priority: peritoneal metastases from colorectal cancer). Mechanism: Patient T cells are engineered with a CAR that binds carcinoembryonic antigen (CEA/CEACAM5) on tumor cells, triggering CAR signaling (CD3ζ/co-stimulation) to activate cytotoxic T-cell killing and cytokine release, leading to lysis of CEA+ tumor cells. Lymphodepleting chemotherapy with fludarabine (purine analog) and cyclophosphamide (alkylator) is given pre-infusion to reduce host lymphocytes and support CAR-T expansion. Targets: CEA-expressing tumor cells in colorectal, gastric, pancreatic, etc., effector cells are autologous T lymphocytes, pathway focus is CAR-mediated T-cell activation and tumor cell apoptosis.