eligibility_summary
Adults with advanced lung cancer after ≥2nd-line therapy (NSCLC/SCLC), CEA-positive (IHC or high serum), measurable disease, ECOG 0-2, ≥12-week survival, adequate organ function, cell collection feasible, contraception, consent. Exclude uncontrolled CNS mets, recent trials/vaccines/therapy, active infection, airway/vessel risk, large effusions, unresolved toxicities, serious cardiac disease, autoimmune/immunosuppression, other malignancy, HBV/HCV/HIV/syphilis, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single-arm, dose-escalation/expansion study testing CEA-targeted CAR-T for CEA+ advanced lung cancer. Interventions: Targeted CEA CAR-T (autologous chimeric antigen receptor T-cell therapy), delivered intravenously or intraperitoneally, given after lymphodepleting chemotherapy with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Mechanism: Patient T cells are engineered to express an anti-CEACAM5 (CEA/CD66e) CAR, binding to CEA on tumor cells triggers CAR signaling (CD3ζ with costimulatory domains), activating T-cell cytotoxicity and cytokine release. The CAR and culture are optimized to enhance persistence. Targets: CEACAM5+ tumor cells, T-cell effector pathways (perforin/granzyme) and immune synapse activation.