“We saw human guinea pigs explode”

Publisher Website
Google Scholar
Abstract
The storyOn 13 March 2006 eight men took part in a “first in man” phase 1 clinical trial of TGN1412, a humanised agonistic anti-CD28 monoclonal antibody being developed by TeGenero to treat various diseases in which T cells are involved, such as chronic inflammatory disorders or haematological malignancies. Within hours those receiving the drug experienced serious side effects caused by a severe inflammatory response, resulting in multiorgan failure due to a “cytokine storm,” for which they were managed in intensive care; some spent more than three months in hospital. Longer term effects for all of the volunteers remain unknown. The story broke in the printed media on 15 March, although radio news bulletins late the previous evening carried the first reports. Headlines were initially conservative but became more dramatic as the story quickly attained “scandal status.”5