Engineered immune cells take on stomach cancer in new trial
NCT ID NCT07333573
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new type of cell therapy called CAR-T cells that are designed to target two proteins (CD73 and AXL) found on stomach cancer cells. The study will enroll 42 people with stage IV stomach cancer that has not responded to standard treatments. The main goals are to check the safety of the therapy and see if it can shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 75 years, male or female. 2. 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. 3. 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 ≥+. 4. ECOG Performance Status score of ≤ 1. 5. Life expectancy of ≥ 3 months. 6. At least one measurable lesion (≥ 1 cm). 7. More than 4 weeks since the last failed treatment, and any toxicities from previous treatments must have recovered to Grade ≤ 1. 8. 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. Exclusion Criteria: 1. Active, known, or highly suspected autoimmune disease. 2. 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). 3. Active, uncontrolled systemic infection. 4. 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. 5. History of severe allergy to other monoclonal antibodies. 6. Intolerance or allergy to the investigational drug. 7. History of interstitial lung disease. 8. 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. 9. Active Hepatitis B (HBsAg positive with detectable HBV DNA), active Hepatitis C (HCV RNA positive), or HIV antibody positive. 10. History of organ transplantation. 11. Active gastrointestinal bleeding, or history of gastrointestinal bleeding within the past month. 12. History of drug abuse, or psychological/psychiatric disorders that may compromise compliance with the study. 13. Any unstable condition or situation that may jeopardize the patient's safety or compliance in the study. 14. Thyroid dysfunction. 15. Prior treatment with any form of adoptive T-cell therapy. 16. Currently receiving anticoagulant or antiplatelet therapy. 17. Major surgery or significant trauma within 4 weeks prior to enrollment. 18. History of other malignant tumors within the past 3 years. 19. Judged by the investigator as unsuitable for cell therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.