Sequential Infusion of Anti-CD19 and Anti-CD20 CAR-T Cells Against Relapsed and Refractory B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03207178|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent or Refractory B Cell Malignancy||Biological: Mixed CD19/CD20 CAR-T Transfer||Phase 1 Phase 2|
Primary Outcome Measure:
The Overall complete remission rate and one-year survival rate of combination transfer of CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is superior to or at least not worse than two kinds of single target treatments in the treatment of CD19+/CD20+ B-cell lymphomas.
The risk of cancer recurrence in a year of combination transfer of CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is inferior to two kinds of single target treatments.
Secondary Outcome Measures:
Evaluate the initial effect time, time to disease progression, and life quality improvement of combination transfer compare to single target treatments.
Evaluate the safety and tolerability of combination transfer compare to single target treatments by observation of high fever duration in patients and testing related cell factor level in peripheral blood.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: Mixed CD19/CD20 CAR-T Transfer
Subjects with CD19+/CD20+ B-cell lymphomas will be infused with CD19-targeting CAR T Cells and CD20-targeting CAR T Cells in one time or in parts
Biological: Mixed CD19/CD20 CAR-T Transfer
Autologous CD19 CAR-T cells and CD20 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.
- Overall complete remission rate [ Time Frame: Half a year ]The complete remission rate will be evaluated by routine methods.
- The initial effect time [ Time Frame: 1 year ]The initial effect time will be recorded.
- The one-year survival rate [ Time Frame: 1 year ]The one-year survival rate will be recorded.
- The safety and the tolerability(incidence of treatment-emergent adverse events defined as dose-limited toxicity) [ Time Frame: 1 month ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- The time to disease progression [ Time Frame: 1 year ]The time to disease progression will be counted after complete remission.
- The one-year recurrence [ Time Frame: 1 year ]The one-year recurrence will be counted after complete remission.
- The life quality improvement [ Time Frame: 1 year ]The life quality improvement will be evaluated by appetite,sleep,pain and mental state.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207178
|Contact: Xin Wang, M.D.||185-1602-2625 ext +email@example.com|
|Contact: Jiang Cao, Ph.D.||159-5146-8263 ext +firstname.lastname@example.org|
|Shanghai Longyao Biotechnology Inc., Ltd.||Recruiting|
|Shanghai, Jingan, China, 200072|
|Contact: Wang Xin, M.D. 185-1602-2625 ext +86 email@example.com|
|Principal Investigator:||Shengqin Ye, M.D.||Shanghai Longyao Biotechnology Inc., Ltd.|