This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
BCMA targeted prime CAR-T cell therapy
920th Hospital of Joint Logistics Support Force
Kunming, Yunnan, China
RECRUITINGAdverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 2 years
The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy
The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG
Time frame: 2 years
Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry
Time frame: 2 years
Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR
Time frame: 2 years
Quantity of clonal plasma cells in bone marrow
In vivo (bone marrow) quantity of clonal plasma cells
Time frame: 1 years
Levels of IL-6 in Serum
In vivo (Serum) quantity of IL-6
Time frame: 1years
Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma
DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)
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Time frame: 2 years
Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma
PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Time frame: 2 years
Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma
OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored)
Time frame: 2 years