Therapeutic anti-CD3 monoclonal antibodies: from bench to bedside

Immunotherapy. 2016 Jul;8(8):889-906. doi: 10.2217/imt-2016-0049. Epub 2016 May 10.


The induction of tolerance is a major goal of immunotherapy. Investigations over the last 20 years have shown that anti-CD3 monoclonal antibodies (mAbs) effectively treat autoimmune disease in animal models and have also shown promise in clinical trials. Tolerance induction by anti-CD3 mAbs is related to the induction of Tregs that control pathogenic autoimmune responses. Here, we review preclinical and clinical studies in which intravenous or mucosal administration of anti-CD3 mAbs has been employed and provide an outlook on future developments to enhance the efficacy of this promising therapeutic approach.

Keywords: Tregs; Type 1 diabetes; autoimmune diseases; foralumab; immune tolerance; immunotherapy; monoclonal CD3 antibodies; otelixizumab; teplizumab; visilizumab.

Publication types

  • Review

MeSH terms

  • Animals
  • Antibodies, Monoclonal / therapeutic use*
  • Autoimmune Diseases / immunology
  • Autoimmune Diseases / therapy*
  • CD3 Complex / immunology*
  • Clinical Trials as Topic
  • Disease Models, Animal
  • Humans
  • Immune Tolerance
  • Immunotherapy / methods*
  • T-Lymphocytes, Regulatory / immunology*


  • Antibodies, Monoclonal
  • CD3 Complex