eligibility_summary
Eligible: ≥18, consent, measurable RECIST lesion, unresectable/metastatic GI adenocarcinoma after standard therapy, CLDN18.2+ by IHC, ECOG 0–1, life expectancy >12 wks, adequate organs, contraception. Exclude: prior CAR‑T, GI bleed/ulcer, CNS mets/cord compression, recent systemic therapy/radiation, anticoagulant/antiplatelet use or bleeding diathesis, infections, recent/other cancers, autoimmune/neuro disease, stroke/seizure, cardiac disease, uncontrolled illness, recent steroids/G‑CSF, major surgery, severe biologic allergy, unresolved tox, pregnancy/breastfeeding, noncompliance, recent live vaccine, concerning medical/psychiatric issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05981235, Phase 1, single‑arm dose‑escalation/expansion in adults with advanced/metastatic CLDN18.2+ gastrointestinal tumors. Intervention: AZD6422, a biological autologous CAR‑T cell therapy (genetically engineered T cells) infused after pre‑conditioning. Mechanism of action: The CAR specifically binds CLDN18.2 on tumor cells, activating T cells independently of native TCR to proliferate, release cytokines, and mediate cytotoxic killing of CLDN18.2‑expressing cells. Targets: CLDN18.2‑positive GI tumor cells, pathways include CAR‑driven T‑cell activation, expansion, and effector cytotoxic pathways. Primary focus: safety, feasibility, cellular kinetics, PD, immunogenicity, and preliminary antitumor activity.