Engineered immune cells take on Hard-to-Treat cancers
NCT ID NCT07266311
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether a patient's own immune cells, modified to target a protein called Claudin18.2, can safely treat advanced solid tumors. Eighteen adults whose cancer has not responded to standard treatments will receive the modified cells and be monitored for side effects and tumor response for up to a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- claudin18.2 CAR T-cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early, small trial (18 people) testing safety first. The treatment may not shrink tumors, and side effects like cytokine release syndrome are possible.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2037
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: * Aged 18 to 75 years at the time of signing the the informed consent form (ICF). * Pathologically confirmed advanced solid tumor and patients have failed at least 2 prior lines of systemic therapy; or patients with advanced pancreatic cancer who have failed at least 1 prior line of systemic therapy. * Tumor tissue testing meets the requirement: Positive for Claudin 18.2 (CLDN18.2) by immunohistochemistry (IHC) staining. * Estimated life expectancy ≥ 12 weeks from the time of screening. * Presence of measurable tumor lesions in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 at screening, within 24 hours prior to apheresis, and at baseline. * Has adequate venous access to allow successful collection of peripheral blood mononuclear cells (PBMCs). * Meets the specified laboratory test criteria at screening and pre-treatment (see Appendix for detailed parameters). For abnormal laboratory results that do not meet the criteria, a retest is permitted within 1 week; if the retest still fails to meet the criteria, the patient is deemed ineligible for screening. * Female patients of childbearing potential must have a negative serum pregnancy test at screening and pre-treatment. They must agree to use a highly effective and reliable contraceptive method for 1 year after the last study treatment. * Male patients who are sexually active with women of childbearing potential must agree to use barrier contraception (unless they have undergone vasectomy) during the study and for 1 year after the last study treatment. * Voluntarily agrees to participate in the clinical trial, has been fully informed of the study details, signs the ICF, and is willing to comply with and capable of completing all study procedures. Exclusion Criteria: * Pregnant or lactating women. * Serologically positive for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV); or positive for Epstein-Barr virus (EBV)-DNA, cytomegalovirus (CMV)-DNA, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid. * Presence of any uncontrolled active infection, including but not limited to active tuberculosis and active hepatitis B virus (HBV) infection (defined as HBsAg positive with detectable HBV-DNA). * Persistent toxicities from prior anti-tumor therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1, except for tolerable events such as alopecia as determined by the investigator. * Known history of active autoimmune diseases (including but not limited to psoriasis, rheumatoid arthritis) or other conditions requiring long-term immunosuppressive therapy. * History of hypersensitivity to immunotherapeutic agents or related drugs, history of severe allergies, or hypersensitivity to any component of CAR-T injection. * Presence of brain metastases or symptoms related to brain metastases. * Patients at high risk of bleeding or perforation (e.g., active gastrointestinal ulcer, recent gastrointestinal bleeding within 3 months). * Patients requiring anticoagulant therapy. * Patients requiring continuous antiplatelet therapy. * History of organ transplantation or awaiting organ transplantation. * History of major surgery or significant trauma within 4 weeks prior to apheresis, or planned major surgery during the study period. * Presence of other serious pre-existing medical conditions that may limit the patient's participation in the study (e.g., severe cardiac, hepatic, or renal dysfunction). * Assessed by the investigator as unable or unwilling to comply with the study protocol requirements. * Presence of clinically significant central nervous system (CNS) disease signs or abnormally significant neurological test results. * Current diagnosis or history of other incurable malignant tumors within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin (which are considered cured after appropriate treatment).
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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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The General Hospital of Western Theater Command
Chengdu, Sichuan, China