A Phase 1/2 interventional study of Multiple sarcoma-specific CAR-T cells and sarcoma vaccines in Sarcoma, Osteoid Sarcoma and Ewing Sarcoma, sponsored by Shenzhen Geno-Immune Medical Institute. Not yet recruiting at 1 site in China. Open to participants aged 1 Year to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Shenzhen Geno-Immune Medical Institute · Phase 1/2, Interventional, and Treatment
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.
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
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.
Exclusion Criteria:
Patients who have confirmed surface antigens including GD2, PSMA, Her2, CD276 or other markers
Biological: Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
1 infusion, CART 1x10\^6\~1x10\^7 cells/kg via IV and vaccines 1-5x10\^6 irradiated cells via subcutaneous injection
Safety 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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Shenzhen Geno-Immune Medical Institute