This is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of CAR-T cells targeting BCMA in the treatment of refractory/relapsed multiple myeloma (r/r MM) who get recurrence and progression after previous CAR-T cell therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) or use their mononuclear cells that preserved in the laboratory for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the re-treatment of CAR-T therapy by intravenous injection.
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Occurrence of treatment related adverse events
assessed by CTCAE v4.0, \>= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Time frame: Day 1-30 days after injection
Anti-myeloma responses
by measuring the changes of aberrant immunoglobulin in serum
Time frame: Day 1-60 months
Anti-myeloma responses
multiple myeloma cells in bone marrow
Time frame: Day 1-60 months
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