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Clin Immunol. 2013 Dec;149(3):268-78. doi: 10.1016/j.clim.2013.05.001. Epub 2013 May 11.

Anti-CD3 clinical trials in type 1 diabetes mellitus.

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MacroGenics, Inc. 9640 Medical Center Drive, Rockville, MD 20850, USA. Electronic address:


Two humanized, anti-CD3 mAbs with reduced FcR binding, teplizumab and otelixizumab, have been evaluated in over 1500 subjects, ages 7-45, with new and recently diagnosed T1D with a range of intravenous doses (3-48mg) and regimens (6-14 days, single or repeat courses). In general, studies that used adequate dosing demonstrated improvement in stimulated C-peptide responses and reduced need for exogenous insulin for two years and even longer after diagnosis. Drug treatment causes a transient reduction in circulating T cells, but the available data suggest that the mechanism of action may involve induction of regulatory mechanisms. The adverse effects of anti-CD3 treatment are infusion-related and transient. The studies have identified significant differences in efficacy among patient groups suggesting that a key aspect for development of this immune therapy is identification of the demographic, metabolic, and immunologic features that distinguish subjects who are most likely to show beneficial clinical responses.


Anti-CD3; Otelixizumab; Teplizumab; Type 1 diabetes mellitus

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