Engineered immune cells take on stomach cancer in early trial
NCT ID NCT07551362
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment using specially designed immune cells (CAR-NK cells) that target two proteins found on stomach cancer cells. The therapy is given to adults with advanced stomach or gastroesophageal junction cancer that has not responded to standard treatments. The goal is to see if it is safe and can shrink tumors, but patients may need ongoing care to manage the disease.
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 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Signed informed consent before any study-specific procedure. * Age 18 to 75 years. * Histologically confirmed unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. * Central confirmation of CLDN18.2-positive disease by immunohistochemistry, defined for this draft as membranous CLDN18.2 expression in at least 10% of tumor cells. HER2 testing is required for all subjects; HER2-positive disease is defined as IHC 3+ or IHC 2+/ISH+ using gastric/GEJ testing criteria. * Disease progression after at least 2 prior systemic regimens for advanced disease, including a fluoropyrimidine and platinum agent unless contraindicated or not tolerated. If HER2-positive, prior HER2-directed therapy is expected unless unavailable, contraindicated, or not tolerated. * At least 1 measurable lesion according to RECIST v1.1. * ECOG performance status 0 or 1. * Life expectancy of at least 12 weeks. * Adequate hematologic, renal, hepatic, pulmonary, and cardiac function. * Recovery of prior treatment-related toxicities to Grade 1 or baseline, except alopecia or stable endocrine replacement therapy. * Willingness to provide archival tumor tissue or fresh biopsy material if archival tissue is inadequate for central biomarker confirmation. * Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during the protocol-defined period Exclusion Criteria: * Prior CLDN18.2-targeted or HER2-targeted genetically modified cell therapy (CAR-T, CAR-NK, TCR-T, or similar). * Active or untreated central nervous system metastases or leptomeningeal disease. * Active uncontrolled infection, including uncontrolled HBV, HCV, or HIV viremia. * Active autoimmune disease requiring systemic immunosuppression. * Clinically significant uncontrolled cardiovascular disease, including recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or severe heart failure. * Active gastrointestinal perforation, uncontrolled upper GI bleeding, clinically significant bowel obstruction, or unstable gastric ulcer. * History of solid-organ transplantation or prior allogeneic hematopoietic stem-cell transplantation with active graft-versus-host disease. * Requirement for systemic corticosteroids above physiologic replacement (for example, \>10 mg/day prednisone equivalent) within 7 days before lymphodepletion. * Pregnancy or breastfeeding. * Another active malignancy requiring systemic therapy, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or other protocol-allowed low-risk malignancies. * Any medical, psychiatric, or social condition that, in the investigator's judgment, would make study participation unsafe or would interfere with interpretation of study results.
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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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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug duo takes aim at hard-to-treat stomach cancer with liver metastases
- New drug cocktail aims to fight tough stomach cancer
- New pill combo aims to fight stomach cancer when first treatment fails