The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03101709|
Recruitment Status : Unknown
Verified March 2017 by Henan Cancer Hospital.
Recruitment status was: Recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma||Drug: Cyclophosphamide Drug: Fludarabine Biological: CART-19||Phase 1|
This is a study for the patients with B cell lymphoma. Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects.
The purpose of this study is to assess ssess the safety and feasibility of CART-19 cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
Fludarabine 25 mg/m2/day IV for 3 days (Day-5 to day-3).
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
- safety as assessed by the occurence of study related adverse events [ Time Frame: 6 months ]monitor the occurence of study related adverse events
- efficacy assessed by anti-tumor activity of CART-19 cells [ Time Frame: 2 years ]anti-tumor activity of CART-19 cells will be determined in a follow-on study
- duration of CART-19 [ Time Frame: 2 years ]Determine duration of in vivo survival of CART-19 cells
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): NCT03101709
|Contact: Yongping Songemail@example.com|
|Henan Cancer Hospital||Recruiting|
|Zhengzhou, Henan, China|
|Contact: Yongping Song -86-13521186987 firstname.lastname@example.org|
|Contact: Yongping Song|
|Principal Investigator: Yongping Song, MD|
|Study Director:||Yongping Song||Henan Cancer Hospital|