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| Name | Class |
|---|---|
| The Second Hospital of Hebei Medical University | OTHER |
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Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 CAR T cells | Experimental | Autologous CD19-targeting CAR T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous CD19-targeting CAR T cells | Biological | Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor load | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| CAR T cell persistence | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| B cell number and immunoglobulins in peripheral blood | The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods | Up to 12 months |
Inclusion Criteria:
The treat history meeting the following criteria:
There is a measurable lesions before treatment at least;
ECOG score≤2;
To be aged 1 to 70 years;
More than a month lifetime from the consent signing date
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianqiang li, PhD & MD | Contact | +8631189928689 | limmune@gmail.com | |
| Jianmin Luo, PhD & MD | Contact | +8631166002304 |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Luo, PhD & MD | The Second Hospital of Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2 Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |