It's a single arm, open label prospective study, in which the safety and efficacy of B Cell Maturation Antigen(BMCA)-targeted CAR-T thearpy are evaluated in refractory/relapsed multiple myeloma patients.
In this trial, T cells are seperated from multiple myeloma patients, and engineered into BMCA-targeted CAR-T cells, these cells are then transfused back into the patients to elimimnate the myeloma cells. In this process, the safety and efficacy of this CAR-T treatment are closely monitored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
a novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen(BMCA)-Targeted CAR-T cells to eliminate myeloma cells.
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
incidence and severity of 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 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 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 36 months after last patient's enrollment
progression free survival
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 36 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 36 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 36 months after last patient's enrollment
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