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| Name | Class |
|---|---|
| Second Xiangya Hospital of Central South University | OTHER |
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This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19-CART with a murine scFv | Experimental | All enrolled patients in this arm will receive CD19-CART with a murine scFv. |
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| humanized CD19-CART | Experimental | All enrolled patients in this arm will receive humanized CD19-CART. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CART | Biological | Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiological assessment | Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan. | Month1 to Month12 |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of CART immunotherapy | After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity | Day 1 to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunxiao Xu, MD | Second Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Bioray Inc. | Shanghai | Shanghai Municipality | 200240 | China |
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Enrolled patients will receive CD19-CART cell immunotherapy.
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