eligibility_summary
Include: 18–75, advanced Claudin18.2+ solid tumor refractory to prior therapy, measurable disease, ECOG 0–1, ≥12‑wk survival, adequate labs/organ function, negative pregnancy test. Exclude: pregnancy/lactation, active infection (HBV/HCV/HIV), prior immune cell or Claudin18.2 therapy, severe prior PD‑1 toxicity, live vaccine <4 wk, allergy to tocilizumab/fludarabine/cyclophosphamide, significant CV/CNS/autoimmune/GI issues or LVEF<50%, surgery <2 wk, O2 dependence, bulky/widespread tumor, uncontrolled effusions, DM/HTN, anticoagulation, difficult airway, investigator decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-center, single-arm, dose-escalation study in advanced Claudin 18.2–positive solid tumors. Intervention: XKDCT086 (iPD-1–Claudin18.2 CAR-T), an autologous, genetically engineered T-cell therapy delivered as an IV cell suspension (single infusion). Mechanism of action: Patient T cells are modified to express a chimeric antigen receptor that recognizes Claudin 18.2 on tumor cells, triggering T-cell activation and cytotoxic killing. The “iPD-1” design is intended to counter PD-1/PD-L1–mediated inhibition, enhancing T-cell function within the tumor microenvironment. Targets and pathways: Tumor cells expressing Claudin 18.2 (tight junction protein), PD-1/PD-L1 immune checkpoint pathway, downstream T-cell activation/cytokine release and expansion/persistence (assessed via pharmacokinetics and cytokine-efficacy correlations). Primary focus: safety, tolerability, secondary: preliminary efficacy, PK, immunogenicity.