title: The storm has cleared: lessons from the CD28 superagonist TGN1412 trial.
abstract: The life-threatening cytokine-release syndrome suffered by six volunteers in a Phase I clinical trial following administration of the CD28 superagonist antibody TGN1412 (developed by TeGenero) in March 2006 was completely unpredicted by the preclinical studies. Here, Thomas Hünig, main founder of TeGenero, describes the recent investigations into what went wrong and discusses the lessons learnt for future clinical trials.
authors.affiliation: Institute for Virology and Immunobiology, Versbacher Strasse 7, D-97078 Würzburg, Germany. huenig@vim.uni-wuerzburg.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Hünig
mesh_terms: D000328:Adult; D000818:Animals; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D006801:Humans; D056747:Immunomodulation; D007963:Leukocytes, Mononuclear / Q000378:metabolism; D008297:Male; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412