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

NCT07333573 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-12

No results posted yet for this study

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

BIOLOGICAL

XW-LTH-03 Infusion

CD73/AXL-Targeting Hypoxia-Inducible CAR-T

Sponsors & Collaborators

  • SHANGHAI SINOBAY BIOTECHNOLOGY CO., LTD

    collaborator UNKNOWN

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07333573 on ClinicalTrials.gov