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NOT YET RECRUITING
NCT07333573
PHASE1/PHASE2

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-01-01

Completion Date

2027-06-30

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

XW-LTH-03 Infusion

CD73/AXL-Targeting Hypoxia-Inducible CAR-T

Locations (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China