This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of LCAR-B4822M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma (r/r MM).
Multiple myeloma (MM) is a usually incurable malignancy of plasma cells. Current therapies for multiple myeloma often cause remissions, but nearly all patients eventually relapse, there is an unmet clinical needs for these patients. B-cell maturation antigen (BCMA) is a protein expressed by normal plasma cells and the malignant plasma cells of multiple myeloma, and it was supposed to be a promising target for r/r MM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the LCAR-B4822M CAR-T Cell Immunotherapy 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
Time frame: Day 1-30 days after injection
Anti-myeloma responses to LCAR-B4822M cell treatment
by measuring the changes of aberrant immunoglobulin in serum
Time frame: Day 1-36 months after injection
Anti-myeloma responses to LCAR-B38M cell treatment
multiple myeloma cells in bone marrow
Time frame: Day 1-36 months after injection
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