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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
CD73/AXL-Targeting Hypoxia-Inducible CAR-T
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 3 months
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 3 months
Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.