Dual-targeting HER2 and PD-L1 CAR-T for Cancers With Pleural or Peritoneal Metastasis

This is an interventional treatment trial for Peritoneal Carcinoma Metastatic Read More

Inclusion Criteria:

1. Male or female, Age 18-65 years old;
2. Estimated life expectancy ≥ 3 months (according to investigator's judgement);
3. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
4. Patients diagnosed as ovarian cancer, non-small cell lung cancer, breast cancer, gastric cancer, etc., accompanied by serous cavity metastasis, have received systemic standard treatment, and have clinical symptoms of serous cavity metastasis;
5. Expressing HER2 >20% of primary tumors or metastatic cells in the serous cavity by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);
6. Absolute neutrophil count ≥ 1×10^9/L, platelet count ≥ 75×10^9/L, absolute lymphocyte count ≥1×10^8/L, hemoglobin ≥ 9.0 g/dl;
7. Creatinine clearance rate ≥60ml/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;
8. Cardiac ejection fraction ≥50%, no pericardial effusion;
9. No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);
10. Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;
11. Patients must take reliable contraceptive measures before entering the trial, during the research process until 1 year after CAR-T infusion; reliable contraceptive measures will be determined by the main investigator or designated personnel;
12. Voluntarily participate in the research, understand and sign the informed consent;
13. The side effect of the last anti-tumor treatment was reduced to ≤1 grade, except for hair loss.

Exclusion Criteria:

1. Allergic to cytokines;
2. Uncontrolled activity infection;
3. Acute or chronic (graft-versus-host disease) GVHD;
4. Accompanied by other uncontrolled malignant tumors;
5. Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
6. Suffer from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
7. Patients with grade 2-3 hypertension or poorly controlled;
8. History of mental illness that is difficult to control;
9. Patients have used immunosuppressive agents for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
10. The existing medical history or mental state history or laboratory abnormalities may increase the risk associated with participating in the study or the administration of the study drug;
11. Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment. If receiving anticoagulant therapy;
12. Pregnant or nursing women, or plan to become pregnant during the treatment period or within 1 year after the treatment ends;
13. Patient suffering from diseases that have signed written informed consent or comply with research procedures; or are unwilling or unable to comply with research requirements.