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The main purpose of this study is to explore the sequential therapeutic effect and evaluate the safety of anti-CD19 or anti-CD20 CAR-T cells briging HSCT in the treatment of relapse/refractory B cell malignancies.
The CD19-targeted CAR-T has shown exellent therapeutic efficiency in B cell malignancies,especially in acute lymphocytic leukemia. Recently the anti-CD20 CAR T cells has been used in the treatment of relapsed/refractory DLBCL and exhibited good clinical outcomes.
However, patients treated with CAR-T may face relapse of CD19 or CD20 mutation. Therefore we attempt to maintain and relieve patients by sequential therapy of the HSCT and hope to combine their advantages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 or CD20 CAR T cells briging HSCT | Experimental | lentiviral transfection and transfuse anti-CD19 or anti-CD20 CAR T cells into patients. Six months later, select appropriate patients to transplant hemopoietic stem cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 or CD20 CAR T cells briging HSCT | Biological | Patients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate of patients treated with anti-CD19 or anti-CD20 CAR T cells | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response rate of anti-CD19 CAR T cell infusion | 4 weeks | |
| Number of patients with adverse events | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects meeting any of the following criteria are not eligible for participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jieping Chen, MD,PhD | Southwest Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital of Third Millitary Medical University | Chongqing | Chongqing Municipality | 400000 | China |
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|
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018941 | Antigens, CD19 |
| ID | Term |
|---|---|
| D015703 | Antigens, CD |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D000944 | Antigens, Differentiation, B-Lymphocyte |
| D015778 | Minor Histocompatibility Antigens |
| D006649 | Histocompatibility Antigens |
| D007519 | Isoantigens |
| D015415 | Biomarkers |
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