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The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.
Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies,and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD22 CAR-T | Experimental | Patients will receive a full dose CART infusion at day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD22-CAR-transduced T cells | Biological | a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Complete Remission Rate (ORR) | 2 years | |
| Disease response(CR, CRi) | 2 years | |
| CART cells persistence in vivo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangding Hu, M.D. | Contact | +86-010-6694-7107 | huliangding@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Liangding Chen, M.D. | Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fengtai District | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 2 years |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |