This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell leukemia.
This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell leukemia. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 0.6-3×106 cells/kg.
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China
Percentage of participants with adverse events.
Time frame: 6 months
Objective remission rate(ORR)
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Time frame: 6 months
Relapse-Free Survival(RFS )
Time frame: 6 months
Overall-Survival(OS)
Time frame: 6 months
Persistence of CAR-T cells in vivo
Time frame: 6 months
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