Six healthy young men were treated for organ failure after experiencing a serious reaction within hours of taking the CD28-SuperMAB in a clinical trial despite being administered at a supposed sub-clinical dose of 0.1 mg per kg which is 500 times lower than the dose found safe in animals.
CD28-SuperMAB is an immunomodulatory drug intended for treatment of B cell chronic lymphocytic leukaemia and rheumatoid arthritis. It is a humanised monocloncal antibody that is a strong agonist for CD28 receptor of the immune T cells.
The MHRA (Medicines and Health products Regulatory Agency) in UK now ensures that committees look at pre-clinical data to decide whether the first dose given to humans is the right dose.
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