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Background: TAK-079 is a subcutaneously (SC) administered, mAb which exhibits more selective binding to human CD38 protein expressed by myeloma cells and less cross reactivity with the CD38 antigen present on red blood cells and platelets. It depletes myeloma cells via apoptosis antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP). TAK-079 was safe and well-tolerated in a first in human study in healthy subjects with potent pharmacodynamic activity when administered as a SC injection (Fedyk et al ASH 2018; abstract 3249).

Methods: A multicenter phase 1 study (NCT03439280) evaluating safety, pharmacokinetic (PK), pharmacodynamics, and efficacy of TAK-079 in patients with heavily pretreated RRMM was initiated. Pt with RRMM were eligible after at least 3 lines of therapy and previous exposure to …