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This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD19 CAR-T | Experimental | Anti-CD19 CAR-T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19 CAR-T | Biological | 1 - 2×10^6 Anti-CD19 CAR-T cells/kg body weigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall responce rate(ORR) | Assessment of ORR (ORR = CR+PR ) at 2 months of treatment | 2 years |
| Overall survival (OS) | Assessment of OS(Overall survival) at 6 months of treatment | 2 years |
| Progression-free survival (PFS) | Assessment of PFS(Progression-free survival ) at 6 months of treatment | 2 years |
| minimal residual disease(MRD) | Assessment of MRD negative overall response rate at 3 months of treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (incidence of adverse events defined as dose-limited toxicity) | Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment. | Study treatment until Week 24 |
| Expression of CD19 CART cells |
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Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ,and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment < 2 years, The specific requirements are as follows:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Li, M.D., Ph.D. | Contact | +86-139-7003-8386 | yx021021@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nangchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow. |
| 2 years |
| Detection of CD19 CART cells | Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR). | 2 years |