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| Name | Class |
|---|---|
| Weifang People's Hospital | OTHER |
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Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICAR19 CAR-T cells | Experimental | Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICAR19 CAR-T cells | Biological | T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the safety of ICAR19 CAR-T cells | To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the anti-tumor effect of ICAR19 CAR-T cells | Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma | 3 years |
| Survival time of ICAR19 T cells in vivo. |
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Inclusion Criteria:
CD19 positive leukemia and lymphoma,relapsed and/or refractory:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiulian Sun, MD.,Ph.D | Contact | (+86) 010-62420659 | xiuliansun@ymcell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weifang People's Hospital | Recruiting | Weifang | Shandong | 261000 | China |
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| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time
| 5 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |