Highly sensitive in vitro cytokine release assay incorporating high-density preculture

References

• Abrahams V, Cambridge G, Lydyard P, Edwards J. 2000. Induction of TNFα production by adhered human monocytes: Key role for FcγRIIIa in rheumatoid arthritis. Arthritis Rheum. 43(3):608–616.
   PubMed Web of Science ®Google Scholar
• Bartholomaeus P, Semmler L, Bukur T, Boisguerin V, Römer P, Tabares P, Chuvpilo S, Tyrsin D, Matskevich A, Hengel H, et al. 2014. Cell contact-dependent priming and Fc interaction with CD32+ immune cells contribute to the TGN1412-triggered cytokine response. J Immunol. 192(5):2091–2098.
   PubMed Web of Science ®Google Scholar
• Brennan F, Morton L, Spindeldreher S, Kiessling A, Allenspach R, Hey A, Muller P, Frings W, Sims J. 2010. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. Mabs. 2(3):233–255.
   PubMed Web of Science ®Google Scholar
• Bugelski P, Achuthanandam R, Capocasale RJ, Treacy G, Bouman-Thio E. 2009. Monoclonal antibody-induced cytokine-release syndrome. Expert Rev Clin Immunol. 5(5):499–521.
   PubMed Web of Science ®Google Scholar
• Chung C. 2008. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist. 13(6):725–732.
   PubMed Web of Science ®Google Scholar
• Eastwood D, Bird C, Dilger P, Hockley J, Findlay L, Poole S, Thorpe S, Wadhwa M, Thorpe R, Stebbings R. 2013. Severity of the TGN1412 trial disaster cytokine storm correlated with IL-2 release. Br J Clin Pharmacol. 76(2):299–315.
   PubMed Web of Science ®Google Scholar
• Eastwood D, Findlay L, Poole S, Bird C, Wadhwa M, Moore M, Burns C, Thorpe R, Stebbings R. 2010. Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells. Br J Pharmacol. 161(3):512–526.
   PubMed Web of Science ®Google Scholar
• Finco D, Grimaldi C, Fort M, Walker M, Kiessling A, Wolf B, Salcedo T, Faggioni R, Schneider A, Ibraghimov A, et al. 2014. Cytokine release assays: Current practices and future directions. Cytokine. 66(2):143–155.
   PubMed Web of Science ®Google Scholar
• Findlay L, Eastwood D, Ball C, Robinson C, Bird C, Wadhwa M, Thorpe S, Thorpe R, Stebbings R, Poole S. 2011. Comparison of novel methods for predicting the risk of pro-inflammatory clinical infusion reactions during monoclonal antibody therapy. J Immunol Meth. 371(1-2):134–142.
   PubMed Web of Science ®Google Scholar
• Findlay L, Eastwood D, Stebbings R, Sharp G, Mistry Y, Ball C, Hood J, Thorpe R, Poole S. 2010. Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412. J Immunol Methods. 352(1-2):1–12.
   PubMed Web of Science ®Google Scholar
• Genentech. 2018. Herceptin (trastuzumab) [package insert]. South San Francisco, (CA): Genentech, Inc.
   Google Scholar
• Genentech. 2019. Rituxan (rituximab) [package insert]. South San Francisco, (CA): Genentech, Inc.
   Google Scholar
• Grimaldi C, Finco D, Fort MM, Gliddon D, Harper K, Helms WS, Mitchell JA, O'Lone R, Parish ST, Piche M-S, et al. 2016. Cytokine release: A workshop proceedings on the state-of-the-science, current challenges and future directions. Cytokine. 85:101–108.
   PubMed Web of Science ®Google Scholar
• Hansel T, Kropshofer H, Singer T, Mitchell J, George A. 2010. The safety and side-effects of monoclonal antibodies. Nat Rev Drug Discov. 9(4):325–338.
   PubMed Web of Science ®Google Scholar
• Hu Y, Turner M, Shields J, Gale M, Hutto E, Roberts B, Siders W, Kaplan J. 2009. Investigation of the mechanism of action of alemtuzumab in a human CD52 transgenic mouse model. Immunology. 128(2):260–270.
   PubMed Web of Science ®Google Scholar
• Hussain K, Hargreaves C, Roghanian A, Oldham R, Chan H, Mockridge C, Chowdhury F, Frendeus B, Harper K, Strefford J, et al. 2015. Upregulation of FcγRIIb on monocytes is necessary to promote the superagonist activity of TGN1412. Blood. 125(1):102–110.
   PubMed Web of Science ®Google Scholar
• Hussain K, Hargreaves C, Rowley T, Sopp J, Latham K, Bhatta P, Sherington J, Cutler R, Humphreys D, Giennie M, et al. 2019. Impact of human FcγR gene polymorphisms on IgG-triggered cytokine release: Critical importance of cell assay format. Front Immunol. 10:390.
   PubMed Web of Science ®Google Scholar
• Kirton C, Gliddon D, Bannish G, Bembridge G, Coney L. 2011. In vitro cytokine release assays: Reducing the risk of adverse events in man. Bioanalysis. 3(23):2657–2663.
   PubMed Web of Science ®Google Scholar
• Kramer P, Kramer S, Guan G. 2004. 17β-Extradiol regulates cytokine release through modulation of CD16 expression in monocytes and monocyte-derived macrophages. Arthritis Rheum. 50(6):1967–1975.
   PubMedGoogle Scholar
• Luhder F, Huang Y, Dennehy K, Guntermann C, Muller I, Winkler E, Kerkau T, Ikemizu S, Davis S, Hanke T, et al. 2003. Topological requirements and signaling properties of T-cell-activating, anti-CD28 antibody superagonists. J Exp Med. 197(8):955–966.
   PubMed Web of Science ®Google Scholar
• Pallardy M, Hunig T. 2010. Primate testing of TGN1412: Right target, wrong cell. Br J Pharmacol. 161(3):509–511.
   PubMed Web of Science ®Google Scholar
• Paul F, Cartron G. 2019. Infusion-related reactions to rituximab: Frequency, mechanisms and predictors. Expert Rev Clin Immunol. 15(4):383–389.
   PubMed Web of Science ®Google Scholar
• Römee R, Foley B, Lenvik T, Wang Y, Zhang B, Ankarlo D, Luo X, Cooley S, Verneris M, Walcheck B, et al. 2013. NK cell CD16 surface expression and function is regulated by a disintegrin and metalloprotease-17 (ADAM17). Blood. 121(18):3599–3608.
   PubMed Web of Science ®Google Scholar
• Römer P, Berr S, Avota E, Na S, Battaglia M, ten Berge I, Einsele H, Hunig T. 2011. Preculture of PBMCs at high cell density increases sensitivity of T-cell responses, revealing cytokine release by CD28 superagonist TGN1412. Blood. 118(26):6772–6782.
   PubMed Web of Science ®Google Scholar
• Sanofi KK. 2015. MabCampath (alemtuzumab) [package insert]. Sanofi K.K., Tokyo, Japan.
   Google Scholar
• Siders W, Shields J, Garron C, Hu Y, Boutin P, Shankara S, Weber W, Roberts B, Kaplan J. 2010. Involvement of neutrophils and natural killer cells in the anti-tumor activity of alemtuzumab in xenograft tumor models. Leuk Lymphoma. 51(7):1293–1304.
   PubMed Web of Science ®Google Scholar
• Stebbings R, Eastwood D, Poole S, Thorpe R. 2013. After TGN1412: Recent developments in cytokine release assays. J Immunotoxicol. 10(1):75–82.
   PubMed Web of Science ®Google Scholar
• Stebbings R, Findlay L, Edwards C, Eastwood D, Bird C, North D, Mistry Y, Dilger P, Liefooghe E, Cludts I, et al. 2007. "Cytokine storm" in the phase I trial of monoclonal antibody TGN1412: Better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol. 179(5):3325–3331.
   PubMed Web of Science ®Google Scholar
• Suntharalingam G, Perry M, Ward S, Brett S, Castello-Cortes A, Brunner M, Panoskaltsis N. 2006. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med. 355(10):1018–1028.
   PubMed Web of Science ®Google Scholar
• Vessillier S, Eastwood D, Fox B, Sathish J, Sethu S, Dougall T, Thorpe S, Thorpe R, Stebbings R. 2015. Cytokine release assays for the prediction of therapeutic mAb safety in first-in man trials-Whole blood cytokine release assays are poorly predictive for TGN1412 cytokine storm. J Immunol Methods. 424:43–52.
   PubMed Web of Science ®Google Scholar
• Wing M, Moreau T, Greenwood J, Smith R, Hale G, Isaacs J, Waldmann H, Lachmann P, Compston A. 1996. 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. 98(12):2819–2826.
   PubMed Web of Science ®Google Scholar
• Wolf B, Morgan H, Krieg J, Gani Z, Milicov A, Warncke M, Brennan F, Jones S, Sims J, Kiessling A. 2012. A whole blood in vitro cytokine release assay with aqueous monoclonal antibody presentation for the prediction of therapeutic protein induced cytokine release syndrome in humans. Cytokine. 60(3):828–837.
   PubMed Web of Science ®Google Scholar
• Yeap W, Wong K, Shimasaki N, Teo E, Quek J, Yong H, Diong C, Bertoletti A, Linn Y, Wong S. 2016. CD16 is indispensable for antibody-dependent cellular cytotoxicity by human monocytes. Sci Rep. 6:34310.
   PubMed Web of Science ®Google Scholar