This study is aimed to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma
This is a study to evaluate the safety, feasibility and efficacy of CAR-T cell therapy in the treatment of relapsed or refractory multiple myeloma. The Main research objectives: To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma. The Secondary research objectives: To evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Volunteers will be treated with BCMA CAR-T cells
25mg/㎡ for D-4、D-3 and D-2
500mg/㎡ for D-3 and D-2
the Second Hospital of HeBei Medical University (HBMU)
Shijiazhuang, Hebei, China
RECRUITINGNumber of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time frame: 28 days
CAR-T Cell expansion level
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Time frame: 24 months
Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Time frame: 24 months
Overall survival time
Overall survival time
Time frame: 24 months
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