It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
patient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma.
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGcomplete remission rate
complete remission rate after treated by CAR-T therapy
Time frame: at the time point 3 months after CAR-T cell transfusion
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of the start of treatment to 24 months after last patient's enrollment
progression free surviva
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment
duration of the CAR-T cells in the patients
time from re-transfusion to date when the modified T cells become non-detectable.
Time frame: from the date of re-transfusison to 24 months after last patient's enrollment
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