The phase 1 leukaemia drug trial ^(18,20)

On 13 March 2006, a first-in-man trial of TGN1412, an immunotherapy drug that targets blood cancer cells, was conducted in a private medical unit in London. Eight healthy male volunteers were recruited. Six were infused with the experimental drug and two with placebo. The drug had successfully undergone pre-clinical studies on monkeys. The dose of TGN1412 that the volunteers received was 500-times lower than the highest dose that monkeys could safely tolerate.

However, within hours of receiving the TGN1412 infusion, all six men experienced headache, back pain, nausea, shivers that culminated rapidly in multi-organ failure requiring admission to the intensive care unit (ICU), ventilator support and dialysis. The cause was later attributed to a cytokine storm, an extreme immune reaction which was not observed in monkeys and deemed to be unprecedented. All six men survived after 4 to 21 days in ICU, high doses of steroids and immunosuppressant. One man had his fingers and toes amputated due to peripheral necrosis (death of tissues in the extremities).

Thorough investigation by regulatory bodies found no deliberate or unintentional violation of the research protocol that was previously approved. However, suggestions were made as to how the research team could have been better prepared to monitor for unanticipated adverse events and manage them. This event subsequently led to a global reform in the way first-in-human studies are conducted.  

David who received the experimental drug spoke about his experience in the documentary ‘The Drug Trial That Went Wrong: Emergency At The Hospital’ (Real Stories, 2018). In further tests done after the trial, David was found to have a blood anomaly that suggested pre-cancerous changes. This led to uncertainties about the long term effects of the drug, and whether it would affect his future children.

Watch what happened since then: (3-minute length)