Volunteers at Risk

Abstract
Clinical research can be a risky endeavor. In this issue of the Journal, Suntharalingam et al.1 describe the events that occurred when six healthy volunteers received a dose (0.1 mg per kilogram of body weight) of TGN1412 — a superagonistic humanized monoclonal antibody that stimulates and expands T-cell populations independently of the ligation of the T-cell receptor. In all six patients, the cytokine-release syndrome developed, including multiorgan failure. Two of the patients required mechanical ventilation, and all received renal-replacement therapy. All six had severe hypotension, and peripheral ischemia developed in one patient to the extent that surgical treatment was required.

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