This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
No.2 Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGNumber of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time frame: 28 days
CAR-T Cell expansion level
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Time frame: 24 months
Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Time frame: 24 months
Overall survival time
Overall survival time
Time frame: 24 months
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25mg/㎡ for D-4、D-3 and D-2
500mg/㎡ for D-3 and D-2