Injury to Research Volunteers — The Clinical-Research Nightmare

In March, after receiving injections of TGN1412, six volunteers became desperately ill, had multiple-organ failure, and were transferred to an intensive care unit. TGN1412 is a humanized monoclonal antibody agonist of the CD28 receptor. Drs. Alastair Wood and Janet Darbyshire write that the serious injuries to these volunteers compel us to reassess the safety of such clinical trials. At 8 a.m. on Monday, March 13, 2006, eight healthy young men entered a trial of a drug under development by the small German immunotherapeutics company TeGenero. Six of the volunteers were assigned to receive active drug, and two were to receive placebo. The trial was being conducted for TeGenero by Parexel, a large contract research organization, at its facility at Northwick Park Hospital outside London. The six volunteers were to be the first humans to receive TGN1412, a humanized monoclonal antibody designed as an agonist of the CD28 receptor on T lymphocytes, which stimulates the production and activation of . . .