A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
NCT ID: NCT02349698
Last Updated: 2019-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2014-12-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.
Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.
Chronic Lymphcytic Leukemia
Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.
Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.
Non-Hodgkin Lymphoma
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.
Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.
Interventions
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Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.
Eligibility Criteria
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Inclusion Criteria
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 4 years to 75 years.
5. Disease progresses but reserves reaction to recent treatments.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
Exclusion Criteria
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. Other situations we think improper for the research.
4 Years
75 Years
ALL
No
Sponsors
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Southwest Hospital, China
OTHER
Responsible Party
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Shiqi Li
Researcher of Biotherpy Center
Principal Investigators
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Cheng Qian, MD, PhD
Role: STUDY_CHAIR
Biotherapy Center of Southwest Hospital
Locations
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Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhi Yang, PhD
Role: backup
References
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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.
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.
Other Identifiers
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TMMU-BTC-001
Identifier Type: -
Identifier Source: org_study_id
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