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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 treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cellsï¼› 2. CD19 CAR-T cells with CRS suppression technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort 1 | Experimental | This cohort will determine the safety and efficacy of CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia |
|
| Experimental: Cohort 2 | Experimental | This cohort will determine the safety and efficacy of CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T cells | Biological | Express a Second Generation 4-1BB: CD19 CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe CRS | The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined | 30 days after infusion of CD19 CAR-T cells |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity. | The efficacy of the CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the CD19 CAR- T cells infusion | 30 days after infusion of CD19 CAR-T cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Tang, PhD | Contact | 8651267781525 | tangxiaowen@suda.edu.cn | |
| Lei Yu, PhD | Contact | 8613818629089 | ylyh188@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Tang, PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of soochow university | Recruiting | Suzhou | Jiangsu | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36105799 | Derived | Gong WJ, Qiu Y, Li MH, Chen LY, Li YY, Yu JQ, Kang LQ, Sun AN, Wu DP, Yu L, Xue SL. Investigation of the risk factors to predict cytokine release syndrome in relapsed or refractory B-cell acute lymphoblastic leukemia patients receiving IL-6 knocking down anti-CD19 chimeric antigen receptor T-cell therapy. Front Immunol. 2022 Aug 29;13:922212. doi: 10.3389/fimmu.2022.922212. eCollection 2022. | |
| 33235353 |
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| CD19 CAR-T cells with CRS suppression technology | Biological | Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology |
|
| Derived |
| Hua J, Zhang J, Zhang X, Wu X, Zhou L, Bao X, Han Y, Miao M, Li C, Fu C, Chen S, Tang X, Wu D, Qiu H. Donor-derived anti-CD19 CAR T cells compared with donor lymphocyte infusion for recurrent B-ALL after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 May;56(5):1056-1064. doi: 10.1038/s41409-020-01140-6. Epub 2020 Nov 24. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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