the Sequential Therapy of CD19-targeted and CD20-targeted CAR-T Cell Therapy for Diffuse Large B Cell Lymphoma(DLBCL)
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|ClinicalTrials.gov Identifier: NCT02737085|
Recruitment Status : Unknown
Verified March 2016 by Jieping Chen, Southwest Hospital, China.
Recruitment status was: Active, not recruiting
First Posted : April 13, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large B-Cell, Diffuse||Biological: Anti-CD19 CAR-T cells and Anti-CD20 CAR-T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||the Sequential Therapy of CD19-targeted and CD20-targeted CAR-T Cell Therapy for Diffuse Large B Cell Lymphoma(DLBCL)|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Diffuse Large B Cell Lymphoma(DLBCL)
The trial will be conducted in a manner of simon two-stage design with Anti-CD19 CAR-T cells and Anti-CD20 CAR-T cells, beginning in the first stage with the aim of over 30% reaction rate among 15 patients with Diffuse Large B Cell Lymphoma(DLBCL). Only when the expected reaction rate is achieved the 30 patients left can be recruited.
Biological: Anti-CD19 CAR-T cells and Anti-CD20 CAR-T cells
Patients receive autologous-derived CD19-targeted CAR-T cells following CD20-targeted CAR-T cells after receiving lymphodepleting chemotherapy.
Other Name: CD19-targeted CAR-T cells and CD20-targeted CAR-T cells
- Adverse Events That Are Related to Treatment [ Time Frame: 2 years ]Determine the toxicity profile of the CD19-targeted and CD20-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737085
|Southwest Hospital of Third Millitary Medical University|
|Chongqing, Chongqing, China, 400000|
|Principal Investigator:||Jieping Chen, MD,PhD||Department of Hematology, Southwest Hospital, Third Military Medical University|