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GLPG5301 is an autologous, second-generation chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA). It incorporates a 4-1BB co-stimulatory domain and is administered as a single fixed-dose intravenous infusion of fresh cells manufactured at the point-of-care. The therapy is designed for adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least two prior lines of therapy. The product leverages a decentralized and automated manufacturing model that enables delivery of the CAR-T product within seven days from leukapheresis to infusion. Clinical evaluation focuses on safety, efficacy (including objective response rate and minimal residual disease status), and feasibility of this rapid manufacturing approach[2][4][5][7].
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