New immune cell therapy takes on tough pancreatic cancer
NCT ID NCT07553793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new type of cell therapy for people with advanced pancreatic cancer that has stopped responding to chemotherapy. The treatment uses a patient's own immune cells, called macrophages, that are engineered in a lab to recognize and attack cancer cells carrying a protein called C-MET. The study will enroll 18 participants to check the safety of the treatment and see if it can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-M-C-MET cells (engineered immune cells)
- What this could lead to
- If this works, it could offer a new treatment option for advanced pancreatic cancer patients who have run out of standard therapies.
- What could go wrong
- This is a very early phase 1 trial with only 18 participants, so it is not yet clear if the treatment is safe or effective. There is a risk of serious side effects like cytokine release syndrome.
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
The first testing in people. Mainly checks safety and dose, usually in a 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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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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. Able to understand and voluntarily sign a written informed consent form. 2. Willing and able to comply with the scheduled visit and treatment plan, laboratory tests, and other study requirements. 3. Aged ≥ 18 years and ≤ 75 years on the day of signing the informed consent form, male or female. 4. ECOG performance status of 0-1. 5. Histologically or cytologically confirmed locally unresectable or abdominopelvic metastatic pancreatic ductal adenocarcinoma. 6. Pancreatic cancer patients who have failed at least one prior line of therapy or are intolerant to such therapy. 7. Medium to high expression of C-MET in pancreatic cancer tissue (defined as ++ or higher, with positive cells \> 25%). 8. At least one measurable lesion according to RECIST v1.1 criteria. 9. Expected survival ≥ 4 months. 10. Adequate organ function as defined by the following laboratory requirements: Note: Subjects must not receive transfusions or growth factor support within 7 days prior to the first dose for hematology assessments. Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. Platelet Count (PLT) ≥ 100 × 10⁹/L. Hemoglobin (HGB) ≥ 90 g/L or ≥ 5.6 mmol/L. Liver and Kidney Function: Creatinine (Cr) ≤ 1.5 × ULN. Albumin ≥ 30 g/L (Albumin infusion is not permitted within 14 days prior to the first dose). Total Bilirubin (TBIL) ≤ 1.5 × ULN (For subjects with liver metastases, TBIL ≤ 3 × ULN). Alanine Aminotransferase (ALT) ≤ 2.5 × ULN. Aspartate Aminotransferase (AST): For subjects with liver metastases, ALT and AST ≤ 5 × ULN. Urinalysis: Urine protein ≤ 1+, without accompanying edema or serum albumin levels below the lower limit of normal (LLN). Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; unless the subject is receiving anticoagulant therapy, in which case PT or aPTT must be within the intended therapeutic range of the anticoagulant. Prothrombin Time (PT) must be within the normal range. 11. Females of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose and must not be lactating. Exclusion Criteria: 1. Received the following anti-tumor treatments prior to apheresis: Immunomodulatory therapy within 7 days; Cytotoxic therapy within 14 days; Investigational medication, targeted therapy, or anti-tumor traditional Chinese medicine within 28 days. 2. Previously received CAR-T cell therapy or other cell therapies targeting any antigen. 3. Liver metastases occupying more than 30% of the total liver volume. 4. History of other concurrent malignancies, except for the following: Completely resected or eradicated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, minute/microscopic papillary thyroid carcinoma, minute/microscopic breast cancer, and other malignancies with an extremely low risk of recurrence or metastasis. 5. Patients with a history of autoimmune disease requiring immunosuppressive medication or hormone therapy (excluding physiological replacement doses). 6. History of severe Central Nervous System (CNS) disease, such as grand mal seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis. 7. Patients with a left ventricular ejection fraction (LVEF) \< 50%, severe structural cardiac abnormalities, or arrhythmias requiring medical treatment. 8. Patients with a history of medical treatment for intestinal obstruction, or those with imaging findings during screening indicating intestinal obstruction requiring treatment. 9. Moderate to severe hepatic steatosis (fatty liver). 10. Patients with moderate to severe cirrhosis (Child-Pugh Class A or worse) and significant portal hypertension. 11. Patients with a history of gastrointestinal bleeding within the past 6 months requiring blood transfusion, emergency room observation, or hospitalization. 12. Patients with active peptic ulcers. 13. Patients with a history of severe intra-abdominal infection. 14. History of abdominal surgery within the past 3 months. 15. Any uncontrolled active infection. 16. Infectious diseases, including but not limited to: 1) Known Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS)-related illness; 2) Hepatitis B (HBsAg positive) or Hepatitis C (HCV RNA positive); 3) Active tuberculosis infection, or currently receiving anti-tuberculosis therapy, or having received anti-tuberculosis therapy within 1 year prior to the first dose of study drug; 4) Positive for Treponema pallidum antibody; 5) Other infectious diseases deemed unsuitable for participation in this study by the investigator. 17. Previous anti-tumor therapy-related Adverse Events (AEs) that have not resolved to Grade 1. 18. Patients with deep vein thrombosis (DVT) or other conditions requiring anticoagulation therapy (e.g., heparin, warfarin). 19. Patients with a history of any arterial embolism. 20. Presence of other serious conditions prior to apheresis that could potentially limit the subject's participation in this trial, such as: Poorly controlled diabetes (glycated hemoglobin \[HbA1c\] \> 8% despite treatment), inadequately controlled hypertension (blood pressure \> 160 mmHg / 100 mmHg despite medication), myocardial infarction within the last 6 months, severe arrhythmia or unstable angina not well controlled by medication, pulmonary embolism, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), etc. 21. Pregnant or lactating women; women or men of childbearing potential planning pregnancy during the study period. 22. Substance abuse (medication or drugs), or clinical, psychological, or social factors that would impair informed consent or study conduct. 23. Patients with a history of severe allergies (e.g., allergies to three or more substances including food, drugs, etc.). 24. Presence of moderate or severe ascites. 25. Currently participating in another interventional clinical trial. 26. Any uncertainty that could affect patient safety or compliance. 27. Any other condition deemed by the investigator to make the subject unsuitable for enrollment.
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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 Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
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Other studies related to the condition(s) this trial covers.
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