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Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Original Article Brief Report Cytokine Storm in a Phase 1 Trial of the Anti-CD28 Monoclonal Antibody TGN1412 Ganesh Suntharalingam, F.R.C.A., Meghan R. Perry, M.R.C.P., Stephen Ward, F.R.C.A., Stephen J.

Brett, M.D., Andrew Castello-Cortes, F.R.C. Himesh Reshammiya New Movie 2014 Download. A., Michael D. Brunner, F.R.C.A., and Nicki Panoskaltsis, M.D., Ph.D. N Engl J Med 2006; 355:1018-1028 DOI: 10.1056/NEJMoa063842. Six healthy young male volunteers at a contract research organization were enrolled in the first phase 1 clinical trial of TGN1412, a novel superagonist anti-CD28 monoclonal antibody that directly stimulates T cells. Within 90 minutes after receiving a single intravenous dose of the drug, all six volunteers had a systemic inflammatory response characterized by a rapid induction of proinflammatory cytokines and accompanied by headache, myalgias, nausea, diarrhea, erythema, vasodilatation, and hypotension. Within 12 to 16 hours after infusion, they became critically ill, with pulmonary infiltrates and lung injury, renal failure, and disseminated intravascular coagulation. Severe and unexpected depletion of lymphocytes and monocytes occurred within 24 hours after infusion.

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All six patients were transferred to the care of the authors at an intensive care unit at a public hospital, where they received intensive cardiopulmonary support (including dialysis), high-dose methylprednisolone, and an anti–interleukin-2 receptor antagonist antibody. Prolonged cardiovascular shock and acute respiratory distress syndrome developed in two patients, who required intensive organ support for 8 and 16 days. Despite evidence of the multiple cytokine-release syndrome, all six patients survived.

Documentation of the clinical course occurring over the 30 days after infusion offers insight into the systemic inflammatory response syndrome in the absence of contaminating pathogens, endotoxin, or underlying disease. On March 13, 2006, eight healthy male volunteers participated in a double-blind, randomized, placebo-controlled phase 1 study of the safety of TGN1412 (TeGenero), a novel monoclonal antibody. The study drug is a recombinantly expressed, humanized superagonist anti-CD28 monoclonal antibody of the IgG4κ subclass that stimulates and expands T cells independently of the ligation of the T-cell receptor. In contrast to other antibodies in clinical use or in clinical trials, TGN1412 directly stimulates the immune response in vivo. In preclinical models, the stimulation of CD28 with TGN1412 (or with murine-antibody counterparts) preferentially activated and expanded type 2 helper T cells and, in particular, CD4+CD25+ regulatory T cells, resulting in transient lymphocytosis with no detectable toxic or proinflammatory effects. A Wellness Way Of Life 10th Edition Quizzes For Fun. On the day of the trial, six of the eight volunteers received TGN1412 and two received placebo.

Subsequently, the six volunteers in the treatment group, who had multiorgan failure with an unknown mechanism and an unpredictable severity, were all admitted to the on-site critical care unit at Northwick Park and St. Mark's Hospital, a National Health Service (NHS) hospital in London. We detail the clinical and pathological findings during the first 30 days after the infusion. Trial Conduct TeGenero sponsored the trial of the monoclonal antibody TGN1412, which was manufactured by Boehringer Ingelheim. Cartier Ring Serial Number Check. The trial was conducted by Parexel International, a contract research organization that operates an independent clinical trials unit in leased space on the premises of Northwick Park and St. Mark's Hospital.

The authors of this report are a group of NHS clinicians who assumed clinical responsibility for the secondary care of these patients after they were transferred to the NHS (between 12 hours [one patient] and 16 hours [five patients] after infusion). The authors have no contractual or operational relationship with either Parexel International or TeGenero. Patients and Sources of Data All six patients provided written informed consent to the NHS for the publication of data obtained during clinical case management. Clinical data obtained before admission to the NHS, and selected laboratory data obtained before the complications were observed, are reproduced here with permission from TeGenero. The trial was suspended owing to the serious adverse events, and no further tests were performed for research purposes. There was full disclosure of drug information, scientific data, and trial documentation by TeGenero and Parexel International, in order to assist in clinical management decisions at the time of the incident. Results All six patients who received the trial drug were male, with a median age of 29.5 years (range, 19 to 34) ( Table 1 Data for All Six Affected Patients on Transfer to the Intensive Care Unit (ICU).