This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of LCAR-B38M 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 and die, an clear unmet clinical needs. As early as mid-2014, the investigators have started to develop a series of proprietary CAR-T products to target B cell maturation antigen (BCMA), a cell surface molecule which the investigator believes to be a desirable target antigen for multiple myeloma. All pre-clinical data and CMC data for LCAR-B38M CAR-T cell technology has been established by mid-2015 and a phase I proof-of-concept clinical trial has been planned since then.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Occurrence of treatment related adverse events as 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 to LCAR-B38M cell treatment
by measuring the changes of aberrant immunoglobulin in serum
Time frame: Day 1-36 months after three split doses
Anti-myeloma responses to LCAR-B38M cell treatment
multiple myeloma cells in bone marrow.
Time frame: Day 1-36 months after three split doses
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.