The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells 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 CAR T cells and IgT cells to treat sarcoma.
Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
Age: ≥ 18 and ≤65 years of age at the time of enrollment;
At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before enrollment;
Side effects of chemotherapy have been well managed;
The disease is progresseing rapidly;
The patient is receiving therapy of other new drugs;
Evidence of tumor potentially causing airway obstruction;
Epilepsy history or other CNS diseases;
Single group
Sarcoma-specific CAR-T cells
Biological/Vaccine1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV
Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Physiological parameter (measuring cytokine response)
Persistence and proliferation of CART cells in patients
The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
Anti-tumor effects
Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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This trial is not recruiting at the moment. You can still explore other options:
