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The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.
The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-targeted CAR-T cells | Biological | This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months.. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure: The overall efficiency | Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated | [Time Frame: 3 years] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guolin Wu | Contact | 13855105487 | wgldoctor@sina.com | |
| Kaiyang Ding | Contact | 13966672170 | dingkaiy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guolin Wu | Investigator associate chief physician | Principal Investigator |
| Kaiyang Ding | Chief physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The west area of the First Affiliated Hospital of University of Science & Technology China | Recruiting | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |