This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
This is a study for the patients with B cell lymphoma. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD28: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 observe the MTD and to assess the safety and feasibility of CART cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Fludarabine 30 mg/m2/day IV for 3 days.
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.
CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
RECRUITINGsafety as assessed by the occurence of study related adverse events
monitor the occurence of study related adverse events
Time frame: 6 months
observe the maximum tolerated dose (MTD)
Time frame: 2 months
objective response rate
CR+PR
Time frame: 2 years
disease control rate
CR+PR+SD
Time frame: 2 years
overall survival
OS
Time frame: 2 years
Progression-Free Survival
Time frame: 2 years
Determine duration of in vivo survival of CD19 CART cells
CD19 CART vector sequences will be performed by Q-PCR
Time frame: 2 years
Peripheral blood cytokines
IL-6、IL-10、IFN-γ、TNF-α
Time frame: 2 months
subgroup of T cell
CD3、CD4、CD8
Time frame: 2 years
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