This is a single-arm, open-label clinical study evaluating the safety and preliminary efficacy of a novel hypoxia-inducible, bispecific CD73/AXL-targeting CAR-T cell product, XW-LTH-03, in patients with stage IV gastric cancer (GC). The primary objective is to assess the safety and tolerability of XW-LTH-03 infusions. Secondary objectives include the evaluation of its antitumor efficacy and the characterization of its pharmacokinetic profile by measuring the in vivo expansion and persistence of the CAR-T cells. Exploratory analyses aim to identify potential biomarkers associated with clinical response and toxicity, as well as to investigate the cellular and molecular mechanisms underlying potential treatment resistance.
Aged 18 to 75 years, male or female.
Clinically judged as unresectable Stage IV gastric cancer that has progressed on or is intolerant to standard therapy, or patients who voluntarily forego standard therapy.
Patients must provide tumor tissue samples, with positive AXL and CD73 confirmed by immunohistochemical (IHC) staining at a central laboratory: AXL positivity rate ≥50% with staining intensity ≥++, and CD73 positivity rate ≥30% with staining intensity ≥+.
ECOG Performance Status score of ≤ 1.
Active, known, or highly suspected autoimmune disease.
Patients with brain metastases who have active central nervous system symptoms. (Note: Patients with brain metastases who completed radiotherapy at least 3 months prior to enrollment and remain asymptomatic from CNS disease may be eligible).
Active, uncontrolled systemic infection.
Receiving high-dose corticosteroids (>10 mg/day of methylprednisolone or equivalent doses of other corticosteroids) or other immunosuppressive therapy within 14 days prior to enrollment.
Single group
XW-LTH-03 Infusion
Biological/VaccineCD73/AXL-Targeting Hypoxia-Inducible CAR-T
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of Dose-Limiting Toxicities (DLTs)
Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
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Shanghai Zhongshan Hospital
Lead sponsor
SHANGHAI SINOBAY BIOTECHNOLOGY CO., LTD
Collaborator
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