This is a clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGsafety as assessed by the occurence of study related adverse events
monitor the occurence of study related adverse events
Time frame: 6 months
efficacy assessed by anti-tumor activity of CART-19 cells
anti-tumor activity of CART-19 cells will be determined in a follow-on study
Time frame: 2 years
duration of CART-19
Determine duration of in vivo survival of CART-19 cells
Time frame: 2 years
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