风暴已过：CD28 超激动剂 TGN1412 试验的教训。
The storm has cleared: lessons from the CD28 superagonist TGN1412 trial.
机构信息
Institute for Virology and Immunobiology, Versbacher Strasse 7, D-97078 Würzburg, Germany.
出版信息
Nat Rev Immunol. 2012 Apr 10;12(5):317-8. doi: 10.1038/nri3192.
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.
2006 年 3 月，在接受 TeGenero 公司研发的 CD28 超级激动剂抗体 TGN1412 治疗后，参与 I 期临床试验的 6 名志愿者出现危及生命的细胞因子释放综合征，这完全出乎临床前研究的预料。在此，TeGenero 的主要创始人托马斯·许尼格（Thomas Hünig）阐述了最近对错误原因的调查，并讨论了为未来临床试验吸取的教训。
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