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| Name | Class |
|---|---|
| Xiangya Hospital of Central South University | OTHER |
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This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T19/CAR-T22 | Experimental | CAR-T19/CAR-T22 (autologous T cells transduced with CD19 / 22 CAR-ζ/4-1BB vector) will be administered to children with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T19/CAR-T22 | Biological | According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10^5/kg-2.5x10^8/kg . |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 | Safety evaluation | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall remission rate | Overall remission rate consists of complete remission rate and partial remission rate of patients being treated with CAR-T19/CAR-T22 | 60 months |
| CAR-T cells testing | The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival. |
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Inclusion Criteria:
Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Zhonghua | Contact | 18938688105 | zh.yang@bindebio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Zhonghua | Shenzhen BinDeBio Tech Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| 60 months |
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and 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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