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.
Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, innovative interventions are needed. Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells. In addition, studies have shown that low dose chemotherapy such as doxorubicin may modulate surface PD-L1 level and enhance immunotherapy effects. This study will combine multiple CAR T cells with low dose chemotherapy to treat sarcoma, and followed by maintenance sarcoma vaccines. The purpose of this clinical trial will assess the feasibility, safety, efficacy and side effects of this combination therapy in patients who have sarcoma that is relapsed or late staged.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
1 infusion, CART 1x10\^6\~1x10\^7 cells/kg via IV and vaccines 1-5x10\^6 irradiated cells via subcutaneous injection
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China
RECRUITINGSafety of CART cells infusion
Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Time frame: 3 months
Overall survival Rate
Percentage of participants with objective response as determined by the investigator based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: 1 year
Treatment response rate of sarcomas
Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on CT imaging analysis.
Time frame: 1 year
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