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.
Signed written informed consent;
Failed to standard chemotherapy regimens;
Relapse after complete remission, high-risk and / or refractory patients ;
Relapse after hematopoietic stem cell transplantation;
Previous history of other malignancy;
Presence of uncontrolled active infection;
Evidence of disorder that need the treatment by glucocorticoids;
Active or chronic GVHD
Single group
BCMA targeted prime CAR-T cells
Biological/VaccineBCMA targeted prime CAR-T cell therapy
Adverse 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)
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
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
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
Quantity of clonal plasma cells in bone marrow
In vivo (bone marrow) quantity of clonal plasma cells
Levels of IL-6 in Serum
In vivo (Serum) quantity of IL-6
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