Researchers refine in vitro test that will reduce the risk of “first in humans” drug trials

doi:10.1136/bmj.a3061

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Susan Mayor

¹London

UK researchers investigating what went wrong in the drug trial with the immunomodulator TGN1412 in 2006, in which six healthy volunteers became critically ill, have developed an in vitro test that could have predicted the drug’s serious side effects before it was tested in humans.

The six men had catastrophic multiorgan failure when they took part in a “first in humans” trial of TGN1412—a monoclonal superagonist of the CD28 T cell surface receptor, which was being tested for use in autoimmune conditions. The drug triggered a systemic inflammatory response with rapid induction of proinflammatory cytokines; this caused a life threatening “cytokine storm,” which had not been predicted from preclinical testing (BMJ 2006;333:570; 10.1136/bmj.333.7568.570).

The UK Medicine and Healthcare Products Regulatory Agency (MHRA) commissioned the government funded National Institute …