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Stage IV Gastric CancerPhase 1/2NCT07333573

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

A Phase 1/2 study testing XW-LTH-03 Infusion in people with Stage IV Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stage IV Gastric Cancer
What is being tested?
XW-LTH-03 Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
1 Jan 2026to 30 Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Life expectancy of ≥ 3 months.
  • At least one measurable lesion (≥ 1 cm).
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  • More than 4 weeks since the last failed treatment, and any toxicities from previous treatments must have recovered to Grade ≤ 1.
  • Adequate organ function and bone marrow reserve, as defined by the following laboratory values within a specified period before enrollment:
  • 1. Hemoglobin (Hb) ≥ 90 g/L. 2. Absolute Neutrophil Count (ANC) ≥ 1.0 × 10^9/L. 3. Absolute Lymphocyte Count ≥ 0.5 × 10^9/L. 4. Platelet count ≥ 100 × 10^9/L. 5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN).
  • 6. Serum amylase and lipase ≤ 1.0 × ULN. 7. Total bilirubin ≤ 1.5 × ULN. 8. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula).
  • 9. Prothrombin Time (PT) or International Normalized Ratio (INR), and Partial Thromboplastin Time (PTT) < 1.5 × ULN. (Patients receiving warfarin or heparin anticoagulation therapy may be enrolled if no underlying abnormality in these parameters is suspected, but require close monitoring with at least weekly testing until INR is stable).
  • 9. Adequate cardiac and pulmonary function. 10. Women of childbearing potential must have a negative pregnancy test within 7 days before treatment initiation. All subjects must agree to use effective contraception during the treatment period and for 1 year thereafter.
  • 11. Voluntary signing of a written informed consent form, good compliance, and willingness to cooperate with follow-up.

Who cannot join

  • 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.
  • History of severe allergy to other monoclonal antibodies.
  • Intolerance or allergy to the investigational drug.
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  • History of interstitial lung disease.
  • Evidence of organ failure:
  • Cardiac: Class III or IV heart failure (per NYHA or other applicable criteria).
  • Hepatic: Class C liver function as per Child-Pugh score.
  • Renal: Renal failure or uremia stage.
  • Pulmonary: Symptoms of severe respiratory failure.
  • Neurological: Impaired consciousness.
  • Active Hepatitis B (HBsAg positive with detectable HBV DNA), active Hepatitis C (HCV RNA positive), or HIV antibody positive.
  • History of organ transplantation.
  • Active gastrointestinal bleeding, or history of gastrointestinal bleeding within the past month.
  • History of drug abuse, or psychological/psychiatric disorders that may compromise compliance with the study.
  • Any unstable condition or situation that may jeopardize the patient's safety or compliance in the study.
  • Thyroid dysfunction.
  • Prior treatment with any form of adoptive T-cell therapy.
  • Currently receiving anticoagulant or antiplatelet therapy.
  • Major surgery or significant trauma within 4 weeks prior to enrollment.
  • History of other malignant tumors within the past 3 years.
  • Judged by the investigator as unsuitable for cell therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhaoming Wang contact

021-64041990

wang.zhaoming@zs-hospital.sh.cn

China1 site

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    Zhaoming Wang, 021-64041990, wang.zhaoming@zs-hospital.sh.cn

Other trials in China

About this study

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

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.

Being tested
XW-LTH-03 Infusion
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XW-LTH-03 InfusionBiological

    CD73/AXL-Targeting Hypoxia-Inducible CAR-T

Study groups in NCT07333573
Study groupRoleWhat they receive
XW-LTH-03 InfusionExperimentalNot described
Receives: Biological: XW-LTH-03 Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: 3 months

  2. Incidence of Dose-Limiting Toxicities (DLTs)

    Measured: 3 months

  3. Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07333573
Sponsor's protocol ID
ZSGC-CD73AXL-CART
Status last verified
Dec 2025
First submitted
23 Sep 2025
Last updated
12 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XW-LTH-03 Infusion in people with Stage IV Gastric Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhaoming Wang (021-64041990, wang.zhaoming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07333573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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