Engineered immune cells take on advanced cancers in early trial
NCT ID NCT07399769
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called MSLN CAR-T for people with advanced solid tumors that have not responded to standard care. The therapy uses a patient's own immune cells, modified in a lab to target a protein called MSLN found on tumor cells. Up to 20 adults will receive chemotherapy before the cell infusion to help the cells work better. The main goal is to see if the treatment is safe and to get an early look at whether it can shrink tumors.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 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 18-75 years (≥18 and ≤75 years), either sex; 2. The subject voluntarily participates in the study and provides written informed consent signed by the subject or his/her legally authorized representative; 3. Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor; according to the AJCC TNM staging system (8th edition, 2017), subjects diagnosed with stage III or stage IV solid malignant tumors; 4. Presence of measurable and evaluable lesions according to RECIST v1.1; 5. Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC); 6. The subject must have received standard first-line therapy and has experienced disease progression or is intolerant to such therapy; 7. The subject is not suitable for curative treatment modalities such as definitive chemoradiotherapy and/or surgery/immune checkpoint inhibitors, or refuses surgical resection; 8. No antibody-based therapy administered within 2 weeks prior to cell therapy; 9. ECOG performance status 0-2; 10. No contraindications to peripheral blood leukapheresis; 11. Estimated life expectancy ≥ 3 months. Exclusion Criteria: 1. History of allergy to any component of the cell product; 2. Any of the following hematologic abnormalities on complete blood count (CBC): WBC ≤ 1 × 10\^9/L, absolute neutrophil count (ANC) ≤ 0.5 × 10\^9/L, absolute lymphocyte count (ALC) ≤ 0.5 × 10\^9/L, or platelets (PLT) ≤ 25 × 10\^9/L; 3. Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg/dL; serum ALT or AST \> 2.5 × ULN; serum creatinine ≥ 2.0 mg/dL; 4. NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) \< 50% on echocardiography; 5. Abnormal pulmonary function with oxygen saturation (SpO₂) \< 92% on room air; 6. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment; 7. Grade 3 hypertension with poor blood pressure control despite medical treatment; 8. History of traumatic brain injury, disturbance of consciousness, epilepsy, or severe cerebral ischemic or hemorrhagic disease; 9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy; 10. Presence of uncontrolled active infection; 11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy; 12. Receipt of a live vaccine within 4 weeks prior to enrollment; 13. Positive test results for HIV, HBV, HCV, and TPPA/RPR, and/or HBV carriers; 14. History of alcohol abuse, illicit drug use, or psychiatric disorders; 15. Participation in any other clinical study within 3 months prior to enrollment; 16. Female subjects meeting any of the following: 1. pregnant or breastfeeding; or 2. planning pregnancy during the study period; or 3. of childbearing potential and unable/unwilling to use effective contraception; 17. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
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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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Shenzhen University General Hospital
RECRUITINGShenzhen, Other (Non U.s.), 518055, China
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