New immune combo takes on tough pancreatic cancer

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years, upper limit ≤ 80 years, gender not limited; 2. Participants must have a histologically or cytologically confirmed diagnosis of advanced pancreatic cancer, with at least one measurable lesion meeting RECIST v1.1 criteria (i.e., a target lesion with a longest diameter ≥10 mm on spiral CT scan, or a lymph node with a short axis ≥15 mm). 3. Tumor tissue positive for Claudin 18.2 by immunohistochemical detection (expression intensity ≥ 2+; expression range ≥ 50%); 4. Meeting the indications for PBMC collection and having no other contraindications for cell collection; 5. Failure of standard second-line treatment or lack of a standard treatment regimen; or signing a refusal to undergo chemotherapy. 6. ECOG score: 0-1; 7. Life expectancy: ≥ 3 months; 8. Toxic reactions from previous chemotherapy and other anti-tumor treatments must be resolved through a washout period (except for residual hair loss), ensuring that all functional parameters meet the inclusion criteria; 9. Sufficient organ function, including: 1. Sufficient immune function, i.e., absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L. 2. Sufficient hematopoietic function, i.e., platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the complete blood count examination. c) Sufficient liver function, i.e., total bilirubin (TBIL) \< 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × ULN. d) Sufficient kidney function, i.e., creatinine (Cr) ≤ 1.5 × ULN. e) Sufficient coagulation function, i.e., prothrombin time (PT) or activated partial thromboplastin time (APTT) \< 1.5 × ULN, and international normalized ratio (INR) \< 1.5. 10. Individuals of fertility must be willing to use contraception; 11. Sufficient understanding and willingness to sign an informed consent form; 12. Willingness to comply with visit schedules, medication plans, laboratory tests, and other trial procedures. Exclusion Criteria: 1. Emergency oncological conditions requiring immediate treatment, such as malignant pericardial effusion or tamponade, superior vena cava obstruction syndrome, spinal cord compression, etc. 2. Significant cardiovascular disease, such as: 1. • A confirmed cardiovascular event within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or previous angioplasty, stent implantation, or coronary artery bypass grafting; 2. • Clinically significant QT interval prolongation (QTcF \> 470ms for women or QTcF \> 450ms for men). 3. Clinically significant bleeding tendency or coagulation disorders, such as hemophilia; 4. HIV infection, syphilis infection, hepatitis B infection, or hepatitis C infection. 5. History of involuntary custody due to mental illness or other mental illness deemed unsuitable for treatment by the treating physician; 6. Accompanied by other autoimmune diseases, or long-term use of immunosuppressants or steroids; 7. Poor patient compliance as assessed by the investigator; 8. Previous treatment with any target CAR-T within 3 months prior to this CAR-T treatment; 9. Uncontrollable active bacterial or fungal infections; 10. Other conditions deemed necessary to be ruled out by the physician.