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The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: CART19 cell and auto-HSCT | Experimental | CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CART19 cell and auto-HSCT | Biological | Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10^7 CART19 cells, Day 1, 30% fraction: 1.5x10^7-1.2x10^8 CART19 cells, Day 2, 60% fraction: 3x10^7-2.4x10^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT | The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment | day 28 |
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Inclusion Criteria:
1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma,who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weihong Chen, M.D., Ph.D. | Contact | 0086-755-83366388 | 8199 | whitney-cindy@hotmail.com |
| Xin Du, M.D., Ph.D. | Contact | 0086-755-83366388 | 8197 | duxingz@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weihong Chen, M.D., Ph.D. | The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University | Principal Investigator |
| Xin Du, M.D., Ph.D. | The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weihong Chen | Recruiting | Shenzhen | Guangdong | 518035 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35126471 | Derived | Zhou W, Chen W, Wan X, Luo C, Du X, Li X, Chen Q, Gao R, Zhang X, Xie M, Wang M. Benefits of Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. Front Genet. 2022 Jan 20;12:815679. doi: 10.3389/fgene.2021.815679. eCollection 2021. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
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|
| Xiaochun Wan, Ph.D. | Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences | Principal Investigator |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |