Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGoccurrence of study related adverse events
safety of CAR-T cells
Time frame: one year
objective response rate
proportion of patients with complete response and partial response
Time frame: three months
survival time of CAR-T cells in vivo
from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo
Time frame: one year
progression-free survival
the enrollment to the first time that disease progression is detected
Time frame: one year
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