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HLX15-SC + lenalidomide + dexamethasone is a combination therapy being developed by Shanghai Henlius Biotech for the treatment of multiple myeloma. HLX15-SC is a subcutaneous formulation of a daratumumab biosimilar, a fully human IgG1κ monoclonal antibody that targets CD38, a protein highly expressed on multiple myeloma cells. The mechanism of action for HLX15-SC involves binding to CD38 and inducing tumor cell death through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). This combination, often referred to as the Rd regimen when paired with the immunomodulatory drug lenalidomide and the corticosteroid dexamethasone, is currently being evaluated in Phase I clinical trials. The study specifically focuses on transplant-ineligible patients with newly diagnosed multiple myeloma to compare the pharmacokinetics, safety, and efficacy of the HLX15-SC-Rd regimen against the reference product Darzalex Faspro in combination with Rd.
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