Immune cell double punch takes on Hard-to-Treat tumors

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 and ≤ 75 years, regardless of gender; 2. Advanced solid tumors with clear pathological confirmation, including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, etc.; at least one measurable lesion meeting RECIST 1.1 criteria (according to RECIST 1.1, the longest diameter of a measurable lesion on spiral CT scan ≥ 10 mm, or the short diameter of a pathological lymph node ≥ 15 mm); 3. Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%); 4. Meets the indications for PBMC collection and has no contraindications for cell collection; 5. Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation); 6. ECOG performance status: 0-1; 7. Life expectancy: ≥ 3 months; 8. Toxicities from prior chemotherapy or other anti-tumor therapies must have resolved after a washout period (except for residual alopecia), ensuring that all organ functions meet the inclusion criteria; 9. Adequate organ function, including: 1. Adequate immune function: absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L. 2. Adequate hematopoietic function: 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 blood count assessment. 3. Adequate liver function: total bilirubin (TBIL) \< 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × ULN. 4. Adequate renal function: creatinine (Cr) ≤ 1.5 × ULN. 5. Adequate coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) \< 1.5 × ULN, and international normalized ratio (INR) \< 1.5. 10. Individuals of childbearing potential must agree to use effective contraception during the study; 11. Ability to understand and willingness to sign a written informed consent form; 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression; 2. Significant cardiovascular disease, including: 1. Documented major cardiovascular events within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or prior angioplasty, stent implantation, or coronary artery bypass grafting; 2. Clinically significant QT interval prolongation (QTcF \> 470 ms for women or QTcF \> 450 ms for men); 3. Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia); 4. Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV); 5. History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial; 6. Concurrent autoimmune diseases, or long-term use of immunosuppressants or systemic corticosteroids; 7. Poor compliance, as assessed by the investigator; 8. Prior treatment with any targeted CAR-T cell therapy within 3 months before this CAR-T infusion; 9. Uncontrolled active bacterial or fungal infections; 10. Any other condition that, in the opinion of the investigator, makes the patient ineligible for the study.