Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors

Inclusion Criteria:

1. Male or female, Age 18-75 years old; If the subjects are over 75 years old, theresearchers will determine whether to enroll according to the basic healthconditions of the subjects, regardless of gender. No upper age limit was set forchest/abdominal reinfusion CAR-T subjects.

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, head and neck cancer, pancreatic cancer, colorectal cancer,transitional cell carcinoma, endometrial carcinoma, sarcoma, glioblastoma,cholangiocarcinoma, etc. have received standard systemic treatment, have systemicmetastasis/serosal cavity metastasis or are not tolerated;

5. Expressing HER2 >20% of primary tumors or metastatic cells in the serous cavity byimmunohistochemistry (IHC) or fluorescence in situ hybridization (FISH);

6. Absolute neutrophil count ≥ 1×10^9/L, platelet count ≥ 75×10^9/L, absolutelymphocyte count ≥0.5×10^8/L, hemoglobin ≥ 8.0 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 orother disease in need of immunosuppressive therapy);

10. Patients must stop chemotherapy and targeted therapy for at least 3 weeks beforestarting treatment;

11. Patients must take reliable contraceptive measures before entering the trial, duringthe research process until 1 year after CAR-T infusion; reliable contraceptivemeasures 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 forhair 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 thenormal 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 organtransplantation, except for recent or current inhaled corticosteroid therapy;

10. The existing medical history or mental state history or laboratory abnormalities mayincrease the risk associated with participating in the study or the administrationof the study drug;

11. Unstable pulmonary embolism, deep venous embolism or other major arterial/venousthromboembolic events occurred within 6 months before enrollment. If receivinganticoagulant therapy;

12. Pregnant or nursing women, or plan to become pregnant during the treatment period orwithin 1 year after the treatment ends;

13. Patient suffering from diseases that have signed written informed consent or complywith research procedures; or are unwilling or unable to comply with researchrequirements.