Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas
The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.
• Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
• Age: ≥ 6 months and ≤80 years of age at the time of enrollment;
• At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment;
• Side effects of chemotherapy have been well managed;
• Confirmed malignant cell expression of CART target antigens by IHC or flow
• Karnofsky /jansky score of 50% or greater;
• Expected survival \> 8 weeks;
• ANC≥ 1×10\^6/L，PLT ≥ 1×10\^8/L;
• Pulse oximetry of≥90% on room air；
⁃ Adequate hepatic function, defined as aspartate aminotransferase(AST)\< 5 times upper limit of normal(ULN),serum bilirubin \< 3 times ULN;
⁃ Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed;
⁃ Patients must have sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight;
⁃ Sign an informed consent and assent.