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| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
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This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .
Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell( CAR-T) and CD19-positive T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia without Chemotherapy pretreatment |
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| Cohort 2 | Experimental | This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia with Chemotherapy pretreatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T cells and CD19 positive feeder T cells | Biological | Detailed Description: Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell ( CAR-T) and CD19-positive T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe CRS | The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Depei Wu, Ph.D | Contact | 86-13328008851 | slxue@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, Ph.D | The First Affiliated Hospital of Soochow University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of soochow university | Recruiting | Suzhou | Jiangsu | 200000 | China |
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| The first affiliated hospital of soochow university | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | China |
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