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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of Next-generation CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC. This is an open-label, single arm study to evaluate the safety and anti- tumor efficacy of Next-generation CD19-UCART in the treatment of relapsed or refractory B-cell hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19-UCART | Experimental | All patients will be treated with at least 1 injection of CD19- UCART. A dose of 5x10^6/kg BW of CD19-UCART will be evaluated. If > 1/6 of DLT occurred, the dose would be reduced to 2.0x10^6/kg BW. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-UCART | Biological | A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLTs) incidence | Incidence of adverse events (AEs) defined as DLTs | Day 0 up to 35 days after T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed. | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | DOR is defined as the time from the first objective response to disease progression or death due to disease relapse or drug-related toxicity | up to 2 years after T cell infusion |
| Progress free survival (PFS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Li, M.D | Contact | +8602164340008 | wli@brlmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Zhang, Prof. | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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PFS is defined as the time from the T cell infusion date to the date of disease progression or death from any cause
| up to 2 years after T cell infusion |
| Overall survival (OS) | OS is defined as the time from the date of leukapheresis until death from any cause | up to 2 years after T cell infusion |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |