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The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Other | Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19. |
|
| Chronic Lymphcytic Leukemia | Other | Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19. |
|
| Non-Hodgkin Lymphoma | Other | Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric Antigen Receptor Modified T cells Targeting CD19 | Biological | T cells modified with CD19 targeted chimeric antigen receptor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of each patient. | Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time of Anti-CD19 CAR T cells in vivo. | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. | 3 years |
| Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Qian, MD,PhD | Contact | 0086-023-68765461 | cqian3184@163.com | |
| Zhi Yang, PhD | Contact | 0086-13206140093 | Lystch@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng Qian, MD, PhD | Biotherapy Center of Southwest Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital of Third Millitary Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34513679 | Derived | Htun KT, Gong Q, Ma L, Wang P, Tan Y, Wu G, Chen J. Successful Treatment of Refractory and Relapsed CNS Acute Lymphoblastic Leukemia With CD-19 CAR-T Immunotherapy: A Case Report. Front Oncol. 2021 Aug 26;11:699946. doi: 10.3389/fonc.2021.699946. eCollection 2021. | |
| 31732519 | Derived | Heng G, Jia J, Li S, Fu G, Wang M, Qin D, Li Y, Pei L, Tian X, Zhang J, Wu Y, Xiang S, Wan J, Zhu W, Zhang P, Zhang Q, Peng X, Wang L, Wang P, Wei Z, Zhang Y, Wang G, Chen X, Zhang C, Sun Y, Zhao W, Fan Y, Yang Z, Chen J, Qian C. Sustained Therapeutic Efficacy of Humanized Anti-CD19 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Acute Lymphoblastic Leukemia. Clin Cancer Res. 2020 Apr 1;26(7):1606-1615. doi: 10.1158/1078-0432.CCR-19-1339. Epub 2019 Nov 15. |
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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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| 12 weeks |
| Maximum tolerated dose (MTD) of CD19 targeted CAR T cells. | To confirm the maximum tolerated dose of CD19 targeted CAR T cells. | 4 weeks |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |