NCT07333573

A Hypoxia-Inducible CAR-T Cell Targeting AXL and CD73 for Advanced Gastric Cancer

A Single-arm, Open-label Phase I/II Study to Evaluate the Safety and Preliminary Efficacy of Hypoxia-Inducible CD73/AXL-Targeting CAR-T Cells (XW-LTH-03) in Patients With Advanced Gastric Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stage IV Gastric Cancer

Interventions

Type	Name	Description
BIOLOGICAL	XW-LTH-03 Infusion	CD73/AXL-Targeting Hypoxia-Inducible CAR-T

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China