A Phase Ia/Ib, Open-label, Single-arm, Dose-escalation and Expansion Study of Specific Dual-targeting VEGFR1 and PD-L1 CAR-T in Cancer Patients With Pleural or Peritoneal Metastases
Serosal cavity metastases of malignant tumor seriously affects the quality of life and survival time of patients with cancers in advanced stage. VEGFR1 is frequently expressed in breast cancer, ovarian cancer, lung cancer, gastric cancer and other malignant tumors and their metastases. The VEGFR1/PD-L1 dual-targeting CAR-T will be investigated in cancer patients with serosal cavity metastases.
• Male or female, Age 18-65 years old; negative results of serum or urine pregnancy test within 48 hours before treatment are needed to provide for fertile women (or women who have undergone sterilization or at least 2 years after menopause can be regarded as infertile);
• 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;
• The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
• Estimated life expectancy ≥ 3 months (according to investigator's judgement);
• Absolute neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 90×10\^9/L, absolute lymphocyte count ≥1×10\^8/L, hemoglobin ≥ 9.0 g/dL;
• Creatinine clearance rate ≥60 mL/min, Serum ALT/AST≤2.5 times of the normal level, and total bilirubin≤1.5 times of the normal level;
• Cardiac ejection fraction ≥50%, no pericardial effusion;
• No other serious diseases (autoimmune diseases or any immune deficiency disease or other disease in need of immunosuppressive therapy);
• Patients must stop chemotherapy and targeted therapy for at least 3 weeks before starting treatment;
⁃ 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;
⁃ Voluntarily participate in the research, understand and sign the informed consent;
⁃ The side effect of the last anti-tumor treatment was reduced to ≤1 grade, except for hair loss.