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A CD33 BiTE antibody is a bispecific T-cell engager (BiTE) designed to simultaneously bind to the CD33 antigen on myeloid leukemia cells and the CD3 receptor on T cells. This dual binding facilitates the formation of an immunological synapse, redirecting the cytotoxic activity of T cells toward the elimination of CD33-positive blasts. CD33 is a transmembrane protein widely expressed on the surface of acute myeloid leukemia (AML) cells but absent from non-hematopoietic tissues and pluripotent hematopoietic stem cells, making it a viable therapeutic target. The most prominent example of this modality is AMG 330, developed by Amgen, which has been investigated in clinical trials for relapsed or refractory AML. Other iterations include half-life extended versions like AMG 673, which incorporates an Fc domain fusion.
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