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| Name | Class |
|---|---|
| Liaocheng People's Hospital | OTHER |
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B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Welgenaleucel (UWC19) | Experimental | The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Welgenaleucel | Genetic | Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The adverse events associated with CAR T cell product infusions are assessed. | The type, frequency, severity, and duration of adverse events will be summarized | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Yi Kuo, PhD | UWELL Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaocheng People Hospital | Liaocheng | Shandong | 252000 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |