• 1
    Hünig T. Manipulation of regulatory T-cell number and function with CD28-specific monoclonal antibodies. Adv Immunol 2007; 95: 111148.
  • 2
    Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, Panoskaltsis N. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355: 10181028.
  • 3
    Duff GW (Chairman). Expert Group on Phase One Clinical Trials: Final Report. London: The Stationery Office, 2006.
  • 4
    Stebbings R, Findlay L, Edwards C, Eastwood D, Bird C, North D, Mistry Y, Dilger P, Liefooghe E, Cludts I, Fox B, Tarrant G, Robinson J, Meager T, Dolman C, Thorpe SJ, Bristow A, Wadhwa M, Thorpe R, Poole S. ‘Cytokine storm’ in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 2007; 179: 33253331.
  • 5
    Eastwood D, Findlay L, Poole S, Bird C, Wadhwa M, Moore M, Burns C, Thorpe R, Stebbings R. Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells. Br J Pharmacol 2010; 161: 512526.
  • 6
    Dustin ML, Olszowy MW, Holdorf AD, Li J, Bromley S, Desai N, Widder P, Rosenberger F, van der Merwe PA, Allen PM, Shaw AS. A novel adaptor protein orchestrates receptor patterning and cytoskeletal polarity in T-cell contacts. Cell 1998; 94: 667677.
  • 7
    Sanchez-Lockhart M, Miller J. Engagement of CD28 outside of the immunological synapse results in up-regulation of IL-2 mRNA stability but not IL-2 transcription. J Immunol 2006; 176: 47784784.
  • 8
    Thoulouze MI, Sol-Foulon N, Blanchet F, Dautry-Varsat A, Schwartz O, Alcover A. Human immunodeficiency virus type-1 infection impairs the formation of the immunological synapse. Immunity 2006; 24: 547561.
  • 9
    Findlay L, Sharp G, Fox B, Ball C, Robinson CJ, Bird C, Stebbings R, Eastwood D, Wadhwa M, Poole S, Thorpe R, Thorpe SJ. Endothelial cells co-stimulate peripheral blood mononuclear cell responses to monoclonal antibody TGN1412 in culture. Cytokine 2011; 55: 141151.
  • 10
    Dhir V, Fort M, Mahmood A, Higbee R, Warren W, Narayanan P, Wittman V. A predictive biomimetic model of cytokine release induced by TGN1412 and other therapeutic monoclonal antibodies. J Immunotoxicol 2012; 9: 3442.
  • 11
    Weissmüller S, Semmler LY, Kalinke U, Christians S, Müller-Berghaus J, Waibler Z. ICOS-LICOS interaction is critically involved in TGN1412-mediated T-cell activation. Blood 2012; 119: 62686277.
  • 12
    Römer PS, Berr S, Avota E, Na SY, Battaglia M, ten Berge I, Einsele H, Hünig T. Preculture of PBMCs at high cell density increases sensitivity of T-cell responses, revealing cytokine release by CD28 super-agonist TGN1412. Blood 2011; 118: 67726782.
  • 13
    Alexander SPH, Mathie A, Peters JA. Guide to receptors and channels (GRAC), 4th edn. Br J Pharmacol 2009; 158: S1254.
  • 14
    Findlay L, Eastwood D, Stebbings R, Sharp G, Mistry Y, Ball C, Hood J, Thorpe R, Poole S. Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412. J Immunol Methods 2010; 352: 112.
  • 15
    Rodríguez-Palmero M, Hara T, Thumbs A, Hünig T. Triggering of T cell proliferation through CD28 induces GATA-3 and promotes T helper type 2 differentiation in vitro and in vivo. Eur J Immunol 1999; 29: 39143924.
  • 16
    Lin CH, Hünig T. Efficient expansion of regulatory T cells in vitro and in vivo with a CD28 superagonist. Eur J Immunol 2003; 33: 626638.
  • 17
    Beyersdorf N, Gaupp S, Balbach K, Schmidt J, Toyka KV, Lin CH, Hanke T, Hünig T, Kerkau T, Gold R. Selective targeting of regulatory T cells with CD28 superagonists allows effective therapy of experimental autoimmune encephalomyelitis. J Exp Med 2005; 202: 445455.
  • 18
    Chung CH. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist 2008; 13: 725732.
  • 19
    Descotes J. Immunotoxicity of monoclonal antibodies. MAbs 2009; 1: 104111.
  • 20
    Bugelski PJ, Achuthanandam R, Capocasale RJ, Treacy G, Bouman-Thio E. Monoclonal antibody-induced cytokine-release syndrome. Expert Rev Clin Immunol 2009; 5: 499521.
  • 21
    Kulkarni HS, Kasi PM. Rituximab and cytokine release syndrome. Case Rep Oncol 2012; 5: 134141.
  • 22
    Suthanthiran M, Fotino M, Riggio RR, Cheigh JS, Stenzel KH. OKT3-associated adverse reactions: mechanistic basis and therapeutic options. Am J Kidney Dis 1989; 14: 3944.
  • 23
    Chatenoud L, Ferran C, Legendre C, Thouard I, Merite S, Reuter A, Gevaert Y, Kreis H, Franchimont P, Bach JF. In vivo cell activation following OKT3 administration. Systemic cytokine release and modulation by corticosteroids. Transplantation 1990; 49: 697702.
  • 24
    Moreau T, Coles A, Wing M, Isaacs J, Hale G, Waldmann H, Compston A. Transient increase in symptoms associated with cytokine release in patients with multiple sclerosis. Brain 1996; 119: 225237.
  • 25
    Wing MG, Moreau T, Greenwood J, Smith RM, Hale G, Isaacs J, Waldmann H, Lachmann PJ, Compston A. Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells. J Clin Invest 1996; 98: 28192826.
  • 26
    Winkler U, Jensen M, Manzke O, Schulz H, Diehl V, Engert A. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (rituximab, IDEC-C2B8). Blood 1999; 94: 22172224.
  • 27
    Walker MR, Makropoulos DA, Achuthanandam R, Van Arsdell S, Bugelski PJ. Development of a human whole blood assay for prediction of cytokine release similar to anti-CD28 superagonists using multiplex cytokine and hierarchical cluster analysis. Int Immunopharmacol 2011; 11: 16971705.
  • 28
    Findlay L, Eastwood D, Ball C, Robinson CJ, Bird C, Wadhwa M, Thorpe SJ, Thorpe R, Stebbings R, Poole S. Comparison of novel methods for predicting the risk of pro-inflammatory clinical infusion reactions during monoclonal antibody therapy. J Immunol Methods 2011; 371: 134142.
  • 29
    Fujishima S, Hoffman AR, Vu T, Kim KJ, Zheng H, Daniel D, Kim Y, Wallace EF, Larrick JW, Raffin TA. Regulation of neutrophil interleukin 8 gene expression and protein secretion by LPS, TNF-alpha, and IL-1 beta. J Cell Physiol 1993; 154: 478485.
  • 30
    Bruhns P, Iannascoli B, England P, Mancardi DA, Fernandez N, Jorieux S, Daëron M. Specificity and affinity of human Fcgamma receptors and their polymorphic variants for human IgG subclasses. Blood 2009; 113: 37163725.
  • 31
    Cerdan C, Martin Y, Courcoul M, Mawas C, Birg F, Olive D. CD28 costimulation up-regulates long-term IL-2R beta expression in human T cells through combined transcriptional and post-transcriptional regulation. J Immunol 1995; 154: 10071013.
  • 32
    Hwang ES, Hong JH, Glimcher LH. IL-2 production in developing Th1 cells is regulated by heterodimerization of RelA and T-bet and requires T-bet serine residue 508. J Exp Med 2005; 202: 12891300.
  • 33
    Annunziato F, Romagnani S. Heterogeneity of human effector CD4+ T cells. Arthritis Res Ther 2009; 11: 257.
  • 34
    Verweij CL, Geerts M, Aarden LA. Activation of interleukin-2 gene transcription via the T-cell surface molecule CD28 is mediated through an NF-kB-like response element. J Biol Chem 1991; 266: 1417914182.
  • 35
    Bilate AM, Lafaille JJ. Induced CD4+Foxp3+ regulatory T cells in immune tolerance. Annu Rev Immunol 2012; 30: 733758.
  • 36
    Lu L, Zhou X, Wang J, Zheng SG, Horwitz DA. Characterization of protective human CD4CD25 FOXP3 regulatory T cells generated with IL-2, TGF-β and retinoic acid. PLoS One 2010; 5: e15150.
  • 37
    Wang J, Ioan-Facsinay A, van der Voort EI, Huizinga TW, Toes RE. Transient expression of FOXP3 in human activated nonregulatory CD4+ T cells. Eur J Immunol 2007; 37: 129138.
  • 38
    Caruso A, Licenziati S, Corulli M, Canaris AD, De Francesco MA, Fiorentini S, Peroni L, Fallacara F, Dima F, Balsari A, Turano A. Flow cytometric analysis of activation markers on stimulated T cells and their correlation with cell proliferation. Cytometry 1997; 27: 7176.