eligibility_summary
Inclusion: 18–70, locally advanced/metastatic gastric/GEJ adenocarcinoma post ≥1 line (failed 2nd), Claudin18.2+ (IHC), ECOG 0–1, life ≥90 d, measurable lesion, consent/biopsy, adequate organs, contraception. Exclusion: HBV/HCV/HIV/TP+, other active cancers, symptomatic brain mets, extensive lung/liver mets, target >4 cm, HER2+, prior CAR‑T, recent treatment/steroids/vaccine, need immunosuppression, unresolved AEs, allergy to study drugs, recent surgery/anesthesia, unstable CV/CNS disease, active infection or GI bleed, active autoimmune, bleeding/thrombotic risk, per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06353152 (Phase 1) tests an autologous Claudin18.2-targeted chimeric antigen receptor (CAR) T-cell therapy (cell/gene therapy, listed as drug: Claudin18.2-Targeted CAR T Cell Injection) in CLDN18.2-positive locally advanced/metastatic gastric or gastroesophageal junction adenocarcinoma. Mechanism: patient T cells are engineered ex vivo to express a CAR that binds Claudin 18.2 on tumor cells, enabling MHC-independent T-cell activation, cytokine release, and cytotoxic killing of CLDN18.2-expressing cancer cells after infusion (single/multiple doses, dose escalation). Targets: tumor cell surface Claudin 18.2 (tight junction claudin family) and downstream CAR-T effector pathways in autologous T lymphocytes (immune-mediated tumor cell lysis). Primary focus: safety, tolerability, and preliminary efficacy.