eligibility_summary
Adults 18–69 with advanced/metastatic, histology‑proven solid tumors (mainly GI) with high CEA (≥2+ in ≥50%), no effective standard therapy, ≥1 measurable lesion ≤6 cm, ECOG ≤2, survival ≥12 wks, adequate marrow/liver/renal function, LVEF ≥50%, SpO2 >90%, apheresis access, contraception. Exclude prior CAR‑T/transplant, active HBV/HCV/HIV/syphilis/TB, severe organ/CNS/autoimmune disease, uncontrolled CV/resp, recent steroids/immunotherapy/RT/surgery/antibodies, other cancer, pregnancy, drug allergy, noncompliance/staff.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm anti-CEA CAR-T for CEA+ locally advanced/metastatic solid tumors. Intervention: Intravenous anti-CEA CAR-T cells (autologous T cells genetically engineered to express a chimeric antigen receptor targeting CEA/CEACAM5). Mechanism: CAR binding to CEA on tumor cells triggers T-cell activation (CD3ζ/costimulatory signaling), leading to perforin/granzyme-mediated cytotoxicity and elimination of CEA+ carcinoma cells. Conditioning: Cyclophosphamide (alkylating agent) and fludarabine (purine analog) for lymphodepletion to enhance CAR-T expansion. Targets: CEA/CEACAM5-expressing epithelial tumor cells (primarily GI cancers), effector cells are CD4+/CD8+ CAR-T. Dose levels: 0.3, 1, 3×10^7 CAR+ cells/kg (3+3 escalation).