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| Name | Class |
|---|---|
| The Beijing Pregene Science and Technology Company, Ltd. | INDUSTRY |
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This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
This is a study for the patients with B cell lymphoma. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. The purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 CART | Experimental | patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Fludarabine 30 mg/m2/day IV for 3 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| safety as assessed by the occurence of study related adverse events | monitor the occurence of study related adverse events | 6 months |
| observe the maximum tolerated dose (MTD) | 2 months | |
| objective response rate | CR+PR | 2 years |
| disease control rate | CR+PR+SD | 2 years |
| overall survival | OS | 2 years |
| Progression-Free Survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determine duration of in vivo survival of CD19 CART cells | CD19 CART vector sequences will be performed by Q-PCR | 2 years |
| Peripheral blood cytokines | IL-6、IL-10、IFN-γ、TNF-α |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| geng tian | Contact | 13724395569 | tiangeng666@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| geng tian | Shenzhen Second People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Shenzhen | Recruiting | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide |
| Drug |
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days. |
|
| CD19 CART | Biological | CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy. |
|
| 2 months |
| subgroup of T cell | CD3、CD4、CD8 | 2 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |