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| Name | Class |
|---|---|
| Gracell Biotechnologies (Shanghai) Co., Ltd. | INDUSTRY |
| Kunming Hope of Health Hospital | OTHER |
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It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD19 Universal CAR-T Cells injection | Experimental | Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19 Universal CAR-T Cells injection | Biological | Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities | Incidence of dose-limiting toxicities as protocol-defined | Up to 4 weeks after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate after CAR-T infusion | At 4,12,24 weeks after CAR-T infusion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanbin Wang, Professor | Contact | 13187424131 | +86 | Sanbin1011@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanbin Wang, Professor | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Recruiting | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
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