eligibility_summary
Adults 18–75, ECOG 0–1, measurable disease, CLDN18.2+ (≥1+ in ≥50%). Cancers: unresectable/metastatic GC/GEJC/EC or PDAC. MR: post‑standard chemo, CR: metastatic SD/PR on 1L SOC and able to continue part (CR1 HER2‑). Key excludes: prior cell/gene therapy, recent anticancer tx, bleeding risk/therapeutic AC, active autoimmune on immunosupp, major cardiac disease, brain mets unless treated/stable (MR only), active infection, allergy to study meds, unresolved tox, recent major surgery, pregnancy, prior allo‑transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05539430 (Phase 1, dose escalation/expansion). Intervention: LB1908, an autologous chimeric antigen receptor T‑cell (CAR‑T) therapy targeting Claudin 18.2 (CLDN18.2). Type: Biological, personalized cellular immunotherapy. Mechanism of action: Patient T cells are engineered to express a CAR that binds CLDN18.2 on tumor cells, antigen engagement triggers T‑cell activation, cytokine release, and perforin/granzyme‑mediated cytotoxicity, leading to lysis of CLDN18.2‑positive cancer cells. Treatment setting: Monotherapy in later lines and consolidation after first‑line chemotherapy in patients with disease control. Targets/cells/pathways: Tumor cells expressing CLDN18.2 (a tight‑junction claudin isoform) in gastric, GEJ, esophageal, and pancreatic adenocarcinomas, engages CAR‑T effector pathways against CLDN18.2. Enrollment requires ≥1+ CLDN18.2 staining in ≥50% of tumor cells by IHC.