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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple sarcoma-specific CAR-T cells | Experimental | Patients who have confirmed surface antigens including GD2, PSMA, Her2, CD276 or other markers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple sarcoma-specific CAR-T cells and sarcoma vaccines | Biological | 1 infusion, CART 1x10^6~1x10^7 cells/kg via IV and vaccines 1-5x10^6 irradiated cells via subcutaneous injection |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CART cells infusion | Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
| Treatment response rate of sarcomas |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lung-Ji Chang, Ph.D | Contact | +86 0755-86573763 | c@szgimi.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Geno-Immune Medical Institute | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| D012512 | Sarcoma, Ewing |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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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.
| 1 year |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |