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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.
Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, novel curative approaches are needed.This study will combine two different ways to fight sarcoma: antibodies and CAR-T cells. Several immune checkpoint antibodies have been examined on various tumors with good outcomes. Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells. Thus, in this study, the 4SCAR-IgT cells targeting sarcoma surface antigens will be infused in dose escalation cohorts.This study will assess the feasibility, safety, efficacy and side effects of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarcoma-specific CAR-T cells | Experimental | Peripheral blood mononuclear cells (PBMCs) of patients who have CD133, GD2, Muc1, CD117 or other marker positive sarcoma will be obtained through apheresis, and T cells will be activated and modified to sarcoma-specific CAR-T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarcoma-specific CAR-T cells | Biological | 1 infusion, for 1x10^6~1x10^7 cells/kg via IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events | Physiological parameter (measuring cytokine response) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lung-Ji Chang, PhD | Contact | +86 0755-86573763 | c@szgimi.org |
| Name | Affiliation | Role |
|---|---|---|
| Lung-Ji Chang, PhD | Shenzhen Geno-Immune Medical Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Recruiting | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31401903 | Derived | Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| D012512 | Sarcoma, Ewing |
| C563326 | Diabetes Mellitus, Insulin-Dependent, 12 |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D012516 | Osteosarcoma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |