A Phase 1 interventional study of CD19/CD20 bispecific CAR-T cells in B-Cell Lymphoma Stage I, Refractory and Relapsed, sponsored by Henan Cancer Hospital. Status unknown at 2 sites in China. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Henan Cancer Hospital · Phase 1, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.
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Exclusion Criteria:
CAR-T cell group
Biological: CD19/CD20 bispecific CAR-T cells
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
occurrence 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
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Henan Cancer Hospital