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| Name | Class |
|---|---|
| Hunan Provincial People's Hospital | OTHER |
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This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Children CD19+ Leukemia Non-Hodgkin lymphoma treatment.
CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Leukemia or Non-Hodgkin lymphoma,blocking the inhibitory PD-L1 signal and stimulating innate T/NK cell activation and expansion, thus make it a tri- functional CAR (Tri-CAR). CD19-TriCAR-T is an autologous tri-functional CAR-T cell therapy, CD19-TriCAR-SILK is an Allogeneic tri-functional CAR- NK cell therapy, patients ineligible for leukapheresis or CAR-T therapy will be recommended for CD19-TriCAR-SILK therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19-TriCAR-T/NK(SILK) | Experimental | CD19-TriCAR-T/SILK cells will be administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-TriCAR-T/SILK | Biological | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells. |
| Measure | Description | Time Frame |
|---|---|---|
| safty (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) | Incidence of treatment-related adverse events as assessed by CTCAE v4.03 | 24 monthes |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma) | Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma | 24 monthes |
| Measure | Description | Time Frame |
|---|---|---|
| Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria) | Partial response rate per the revised International Working Group (IWG) Response Criteria | 24 monthes |
| Duration of Response (The time from response to relapse or progression) |
Inclusion Criteria:
For children CD19 positive B cell leukemia:
For children CD19 positive B cell lymphoma:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangling He | Contact | +86 13873102615 | hexiangl@163.com | |
| Keke Chen | Contact | +86 13974931408 | chenkeke1982@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangling He | Hunan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410005 | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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The time from response to relapse or progression |
| 24 monthes |
| Progression Free Survival (The time from the first day of treatment to the date on which disease progresses) | The time from the first day of treatment to the date on which disease progresses | 24 monthes |
| Overall Survival (The number of patient alive, with or without signs of cancer) | The number of patient alive, with or without signs of cancer | 24 monthes |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |