Volunteers at Risk
Open Access
- 7 September 2006
- journal article
- editorial
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 355 (10) , 1060-1061
- https://doi.org/10.1056/nejme068175
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.Keywords
This publication has 2 references indexed in Scilit:
- T-Cell Costimulation — Biology, Therapeutic Potential, and ChallengesNew England Journal of Medicine, 2006
- Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412New England Journal of Medicine, 2006