リケラボ論文検索は、全国の大学リポジトリにある学位論文・教授論文を一括検索できる論文検索サービスです。

リケラボ 全国の大学リポジトリにある学位論文・教授論文を一括検索するならリケラボ論文検索大学・研究所にある論文を検索できる

リケラボ 全国の大学リポジトリにある学位論文・教授論文を一括検索するならリケラボ論文検索大学・研究所にある論文を検索できる

大学・研究所にある論文を検索できる 「Studies on the Methodology for Hazard Identification and Mitigation of Cytokine Release Syndrome Caused by Monoclonal Antibody Pharmaceuticals」の論文概要。リケラボ論文検索は、全国の大学リポジトリにある学位論文・教授論文を一括検索できる論文検索サービスです。

コピーが完了しました

URLをコピーしました

論文の公開元へ論文の公開元へ
書き出し

Studies on the Methodology for Hazard Identification and Mitigation of Cytokine Release Syndrome Caused by Monoclonal Antibody Pharmaceuticals

岩田, 良香 筑波大学 DOI:10.15068/00160450

2020.07.22

概要

In this work, I focused on cytokine release syndrome (CRS), a type of immunotoxicity caused by monoclonal antibody (mAb) pharmaceuticals. Severe CRS can cause fatal or life-threatening reactions. The clinical signs of CRS correlate with immune cell activation following a cascade of systemic cytokine release. In the first-in-human trials to evaluate pharmaceutical candidates, the safety of clinical trial subjects is the priority. Identification of potential risk of CRS and appropriate strategies to mitigate the risk are critical aspects of the successful safety management of CRS. In 2006, a CD28 superagonist (CD28SA), TGN1412, caused severe CRS in a first-in-human trial. Preclinical studies using experimental animals failed to predict this CRS because of species differences in the immune system. The use of in vitro cytokine release assays with human cells are useful to identify potential risks of CRS. There are two major testing platforms for the detection of potential CRS risks: one composed of whole blood with aqueous-phase test articles (i.e. the whole blood cytokine assay [WBCA]), and the other composed of peripheral blood mononuclear cells (PBMCs) with solid-phase test articles (i.e. the PBMC assay). First, I determined an appropriate sample size and confirmed the suitability of the WBCA as a hazard identification tool for CRS. Next, I compared the cytokine producing cells after stimulation with the TGN1412 analogue, CD28SA, in the WBCA and the PBMC assay, and showed that different immune cells generate a positive response in the two in vitro assays, causing differences in the response to CD28SA. The results emphasize the need to understand the characteristics of these in vitro assays and to establish an optimal method that suits the mechanism of a therapeutic mAb candidate. It is currently possible to detect the potential risks of CRS, but it is still difficult to manage CRS. CD3 bispecific constructs show promising potential for cancer immune therapy, but they frequently induce CRS in clinical use. Finally, I investigated the effectiveness of an ascending dose regimen to mitigate CRS caused by a CD3 bispecific construct, ERY22, in cynomolgus monkeys, and indicated that ascending doses can markedly mitigate CRS. The results from this study provide useful information for CRS hazard identification and CRS mitigation of mAb pharmaceuticals.

この論文で使われている画像

参考文献

Abdulkhaleq, L.A., Assi, M.A., Abdullah, R., Zamri-Saad, M., Taufiq-Yap, Y.H., Hezmee, M.N.M., 2018. The crucial roles of inflammatory mediators in inflammation: A review. Veterinary world 11, 627-635.

Aerts, J.G., Hegmans, J.P., 2013. Tumor-specific cytotoxic T cells are crucial for efficacy of immunomodulatory antibodies in patients with lung cancer. Cancer Res 73, 2381-2388.

Amgen Inc. (2015): Vectibix® (panitumumab) [package insert]. Thousand Oaks, CA.

Andisheh-Tadbir, A., Ashraf, M.J., Gudarzi, A., Zare, R., 2019. Evaluation of Glypican-3 expression in benign and malignant salivary gland tumors. Journal of oral biology and craniofacial research 9, 63-66.

Attarwala, H., 2010. TGN1412: From Discovery to Disaster. Journal of young pharmacists : JYP 2, 332-336.

Bachmann, M.F., Hunziker, L., Zinkernagel, R.M., Storni, T., Kopf, M., 2004. Maintenance of memory CTL responses by T helper cells and CD40-CD40 ligand: antibodies provide the key. Eur J Immunol 34, 317-326.

Bailey, L., Moreno, L., Manigold, T., Krasniqi, S., Kropshofer, H., Hinton, H., Singer, T., Suter, L., Hansel, T.T., Mitchell, J.A., 2013. A simple whole blood bioassay detects cytokine responses to anti-CD28SA and anti-CD52 antibodies. Journal of pharmacological and toxicological methods 68, 231-239.

Ball, C., Fox, B., Hufton, S., Sharp, G., Poole, S., Stebbings, R., Eastwood, D., Findlay, L., Parren, P.W., Thorpe, R., Bristow, A., Thorpe, S.J., 2012. Antibody C region influences TGN1412- like functional activity in vitro. J Immunol 189, 5831-5840.

Bargou, R., Leo, E., Zugmaier, G., Klinger, M., Goebeler, M., Knop, S., Noppeney, R., Viardot, A., Hess, G., Schuler, M., Einsele, H., Brandl, C., Wolf, A., Kirchinger, P., Klappers, P., Schmidt, M., Riethmuller, G., Reinhardt, C., Baeuerle, P.A., Kufer, P., 2008. Tumor regression in cancer patients by very low doses of a T cell-engaging antibody. Science 321, 974-977.

Barrett, D.M., Teachey, D.T., Grupp, S.A., 2014. Toxicity management for patients receiving novel Tcell engaging therapies. Current opinion in pediatrics 26, 43-49.

Barrington, R., Zhang, M., Fischer, M., Carroll, M.C., 2001. The role of complement in inflammation and adaptive immunity. Immunol Rev 180, 5-15.

Beers, S.A., Glennie, M.J., White, A.L., 2016. Influence of immunoglobulin isotype on therapeutic antibody function. Blood 127, 1097-1101.

Bertoletti, A., Ferrari, C., Fiaccadori, F., Penna, A., Margolskee, R., Schlicht, H.J., Fowler, P., Guilhot, S., Chisari, F.V., 1991. HLA class I-restricted human cytotoxic T cells recognize endogenously synthesized hepatitis B virus nucleocapsid antigen. Proc Natl Acad Sci U S A 88, 10445-10449.

Beyersdorf, N., Gaupp, S., Balbach, K., Schmidt, J., Toyka, K.V., Lin, C.H., Hanke, T., Hunig, T., Kerkau, T., Gold, R., 2005a. Selective targeting of regulatory T cells with CD28 superagonists allows effective therapy of experimental autoimmune encephalomyelitis. J Exp Med 202, 445-455.

Beyersdorf, N., Hanke, T., Kerkau, T., Hunig, T., 2005b. Superagonistic anti-CD28 antibodies: potent activators of regulatory T cells for the therapy of autoimmune diseases. Annals of the rheumatic diseases 64 Suppl 4, iv91-95.

Boehm, T., 2011. Design principles of adaptive immune systems. Nat Rev Immunol 11, 307-317.

Boyman, O., Purton, J.F., Surh, C.D., Sprent, J., 2007. Cytokines and T-cell homeostasis. Curr Opin Immunol 19, 320-326.

Brekke, O.H., Sandlie, I., 2003. Therapeutic antibodies for human diseases at the dawn of the twentyfirst century. Nat Rev Drug Discov 2, 52-62.

Brennan, F.R., Morton, L.D., Spindeldreher, S., Kiessling, A., Allenspach, R., Hey, A., Muller, P.Y., Frings, W., Sims, J., 2010. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies. MAbs 2, 233-255.

Bugelski, P.J., Achuthanandam, R., Capocasale, R.J., Treacy, G., Bouman-Thio, E., 2009. Monoclonal antibody-induced cytokine-release syndrome. Expert Rev Clin Immunol 5, 499-521.

Buysmann, S., Hack, C.E., van Diepen, F.N., Surachno, J., ten Berge, I.J., 1997. Administration of OKT3 as a two-hour infusion attenuates first-dose side effects. Transplantation 64, 1620-1623.

Cambier, J.C., Gauld, S.B., Merrell, K.T., Vilen, B.J., 2007. B-cell anergy: from transgenic models to naturally occurring anergic B cells? Nat Rev Immunol 7, 633-643.

Cassidy, J.T., Nordby, G.L., Dodge, H.J., 1974. Biologic variation of human serum immunoglobulin concentrations: sex-age specific effects. Journal of chronic diseases 27, 507-516.

Chung, C.H., 2008. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist 13, 725-732.

Cole, D.S., Morgan, B.P., 2003. Beyond lysis: how complement influences cell fate. Clinical science 104, 455-466.

Davila, M.L., Riviere, I., Wang, X., Bartido, S., Park, J., Curran, K., Chung, S.S., Stefanski, J., Borquez-Ojeda, O., Olszewska, M., Qu, J., Wasielewska, T., He, Q., Fink, M., Shinglot, H., Youssif, M., Satter, M., Wang, Y., Hosey, J., Quintanilla, H., Halton, E., Bernal, Y., Bouhassira,

D.C., Arcila, M.E., Gonen, M., Roboz, G.J., Maslak, P., Douer, D., Frattini, M.G., Giralt, S., Sadelain, M., Brentjens, R., 2014. Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Science translational medicine 6, 224ra225.

Dettmar, K., Seitz-Merwald, I., Lindemann, C., Schroeder, P., Seimetz, D., Atz, J., 2012. Transient lymphocyte decrease due to adhesion and migration following catumaxomab (anti-EpCAM x anti-CD3) treatment in vivo. Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico 14, 376-381.

Dilek, N., Poirier, N., Hulin, P., Coulon, F., Mary, C., Ville, S., Vie, H., Clemenceau, B., Blancho, G., Vanhove, B., 2013. Targeting CD28, CTLA-4 and PD-L1 costimulation differentially controls immune synapses and function of human regulatory and conventional T-cells. PLoS One 8, e83139.

Drouin, S.M., Kildsgaard, J., Haviland, J., Zabner, J., Jia, H.P., McCray, P.B., Jr., Tack, B.F., Wetsel, R.A., 2001. Expression of the complement anaphylatoxin C3a and C5a receptors on bronchial epithelial and smooth muscle cells in models of sepsis and asthma. J Immunol 166, 2025- 2032.

Duff, G.W.C., 2006. EXPERT SCIENTIFIC GROUP ON PHASE ONE CLINICAL TRIALS.

Eastwood, D., Bird, C., Dilger, P., Hockley, J., Findlay, L., Poole, S., Thorpe, S.J., 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, 299-315.

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, 512-526.

EMA, 2007. GUIDELINE ON STRATEGIES TO IDENTIFY AND MITIGATE RISKS FOR FIRSTIN-HUMAN CLINICAL TRIALS WITH INVESTIGATIONAL MEDICINAL PRODUCTS. EMEA/CHMP/SWP/28367/07

EMA, 2017. Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. EMEA/CHMP/SWP/28367/07 Rev. 1

Finco, D., Grimaldi, C., Fort, M., Walker, M., Kiessling, A., Wolf, B., Salcedo, T., Faggioni, R., Schneider, A., Ibraghimov, A., Scesney, S., Serna, D., Prell, R., Stebbings, R., Narayanan, P.K., 2014. Cytokine release assays: current practices and future directions. Cytokine 66, 143-155.

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, 1-12.

Foreback, J.L., Remick, D.G., Crockett-Torabi, E., Ward, P.A., 1997. Cytokine responses of human blood monocytes stimulated with Igs. Inflammation 21, 501-517.

Franks, Z., Carlisle, M., Rondina, M.T., 2015. Current challenges in understanding immune cell functions during septic syndromes. BMC immunology 16, 11.

Friberg, G., Reese, D., 2017. Blinatumomab (Blincyto): lessons learned from the bispecific t-cell engager (BiTE) in acute lymphocytic leukemia (ALL). Annals of oncology : official journal of the European Society for Medical Oncology 28, 2009-2012.

Gerlach, H., 2016. Agents to reduce cytokine storm. F1000Res 5, 2909.

Giavridis, T., Van der Stegen, S.J.C., Eyquem, J., Hamieh, M., Piersigilli, A., Sadelain, M., 2018. CAR T cell-induced cytokine release syndrome is mediated by macrophages and abated by IL-1 blockade. Nat Med 24, 731-738.

Gulati, K., Ray, A. Immunotoxicity. Handbook of Toxicology of Chemical Walfare Agents, Section III - Target Organ Toxicity, Chapter 40

Grignani, G., Maiolo, A., 2000. Cytokines and hemostasis. Haematologica 85, 967-972.

Grimaldi, C., Finco, D., Fort, M.M., Gliddon, D., Harper, K., Helms, W.S., Mitchell, J.A., O'Lone, R., Parish, S.T., Piche, M.S., Reed, D.M., Reichmann, G., Ryan, P.C., Stebbings, R., Walker, M., 2016. Cytokine release: A workshop proceedings on the state-of-the-science, current challenges and future directions. Cytokine 85, 101-108.

Guo, F., Iclozan, C., Suh, W.K., Anasetti, C., Yu, X.Z., 2008. CD28 controls differentiation of regulatory T cells from naive CD4 T cells. J Immunol 181, 2285-2291.

Hale, G., Rebello, P., Brettman, L.R., Fegan, C., Kennedy, B., Kimby, E., Leach, M., Lundin, J., Mellstedt, H., Moreton, P., Rawstron, A.C., Waldmann, H., Osterborg, A., Hillmen, P., 2004. Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration. Blood 104, 948-955.

Hanke, T., 2006. Lessons from TGN1412. Lancet 368, 1569-1570; author reply 1570.

Hansel, T.T., Kropshofer, H., Singer, T., Mitchell, J.A., George, A.J., 2010. The safety and side effects of monoclonal antibodies. Nat Rev Drug Discov 9, 325-338.

Herter, S., Herting, F., Mundigl, O., Waldhauer, I., Weinzierl, T., Fauti, T., Muth, G., ZieglerLandesberger, D., Van Puijenbroek, E., Lang, S., Duong, M.N., Reslan, L., Gerdes, C.A., Friess, T., Baer, U., Burtscher, H., Weidner, M., Dumontet, C., Umana, P., Niederfellner, G., Bacac, M., Klein, C., 2013. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Molecular cancer therapeutics 12, 2031-2042.

Hoffman, L.M., Gore, L., 2014. Blinatumomab, a Bi-Specific Anti-CD19/CD3 BiTE((R)) Antibody for the Treatment of Acute Lymphoblastic Leukemia: Perspectives and Current Pediatric Applications. Frontiers in oncology 4, 63.

Hoffmann, P., Hofmeister, R., Brischwein, K., Brandl, C., Crommer, S., Bargou, R., Itin, C., Prang, N., Baeuerle, P.A., 2005. Serial killing of tumor cells by cytotoxic T cells redirected with a CD19-/CD3-bispecific single-chain antibody construct. International journal of cancer 115, 98-104.

Holland, M., Hewins, P., Goodall, M., Adu, D., Jefferis, R., Savage, C.O., 2004. Anti-neutrophil cytoplasm antibody IgG subclasses in Wegener's granulomatosis: a possible pathogenic role for the IgG4 subclass. Clin Exp Immunol 138, 183-192.

Horton, H.M., Chu, S.Y., Ortiz, E.C., Pong, E., Cemerski, S., Leung, I.W., Jacob, N., Zalevsky, J., Desjarlais, J.R., Stohl, W., Szymkowski, D.E., 2011. Antibody-mediated coengagement of FcgammaRIIb and B cell receptor complex suppresses humoral immunity in systemic lupus erythematosus. J Immunol 186, 4223-4233.

Hussain, A., Pankhurst, T., Goodall, M., Colman, R., Jefferis, R., Savage, C.O., Williams, J.M., 2009. Chimeric IgG4 PR3-ANCA induces selective inflammatory responses from neutrophils through engagement of Fcgamma receptors. Immunology 128, 236-244.

ICH, 2011. ICH HARMONISED TRIPARTITE GUIDELINE: PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS S6(R1)

Ishiguro, T., Sano, Y., Komatsu, S.I., Kamata-Sakurai, M., Kaneko, A., Kinoshita, Y., Shiraiwa, H., Azuma, Y., Tsunenari, T., Kayukawa, Y., Sonobe, Y., Ono, N., Sakata, K., Fujii, T., Miyazaki, Y., Noguchi, M., Endo, M., Harada, A., Frings, W., Fujii, E., Nanba, E., Narita, A., Sakamoto, A., Wakabayashi, T., Konishi, H., Segawa, H., Igawa, T., Tsushima, T., Mutoh, H., Nishito, Y., Takahashi, M., Stewart, L., ElGabry, E., Kawabe, Y., Ishigai, M., Chiba, S., Aoki, M., Hattori, K., Nezu, J., 2017. An anti-glypican 3/CD3 bispecific T cell-redirecting antibody for treatment of solid tumors. Sci Transl Med 9, eaal4291. Jilani, I., Keating, M., Giles, F.J., O'Brien, S., Kantarjian, H.M., Albitar, M., 2004. Alemtuzumab: validation of a sensitive and simple enzyme-linked immunosorbent assay. Leukemia research 28, 1255-1262. Yam-Puc, J.C., Zhang,L., Zhang, Y., Toellner, K.M., 2018. Role of B-cell receptors for B-cell development and antigen-induced differentiation. F1000Research.

Kasahara, K., Strieter, R.M., Chensue, S.W., Standiford, T.J., Kunkel, S.L., 1991. Mononuclear cell adherence induces neutrophil chemotactic factor/interleukin-8 gene expression. J Leukoc Biol 50, 287-295.

Klinger, M., Brandl, C., Zugmaier, G., Hijazi, Y., Bargou, R.C., Topp, M.S., Gokbuget, N., Neumann, S., Goebeler, M., Viardot, A., Stelljes, M., Bruggemann, M., Hoelzer, D., Degenhard, E., Nagorsen, D., Baeuerle, P.A., Wolf, A., Kufer, P., 2012. Immunopharmacologic response of patients with B-lineage acute lymphoblastic leukemia to continuous infusion of T cellengaging CD19/CD3-bispecific BiTE antibody blinatumomab. Blood 119, 6226-6233.

Kontermann, R.E., Brinkmann, U., 2015. Bispecific antibodies. Drug Discov Today 20, 838-847.

Kulkarni, H.S., Kasi, P.M., 2012. Rituximab and cytokine release syndrome. Case reports in oncology 5, 134-141.

Lee, D.W., Gardner, R., Porter, D.L., Louis, C.U., Ahmed, N., Jensen, M., Grupp, S.A., Mackall, C.L., 2014. Current concepts in the diagnosis and management of cytokine release syndrome. Blood 124, 188-195.

Leung, S., Liu, X., Fang, L., Chen, X., Guo, T., Zhang, J., 2010. The cytokine milieu in the interplay of pathogenic Th1/Th17 cells and regulatory T cells in autoimmune disease. Cellular & molecular immunology 7, 182-189.

Li, F., Ravetch, J.V., 2012. Apoptotic and antitumor activity of death receptor antibodies require inhibitory Fcgamma receptor engagement. Proc Natl Acad Sci U S A 109, 10966-10971.

Li, J., Piskol, R., Ybarra, R., Chen, Y.J., Li, J., Slaga, D., Hristopoulos, M., Clark, R., Modrusan, Z., Totpal, K., Junttila, M.R., Junttila, T.T., 2019. CD3 bispecific antibody-induced cytokine release is dispensable for cytotoxic T cell activity. Science translational medicine 11.

Libby, P., 2002. Inflammation in atherosclerosis. Nature 420, 868-874.

Litman, G.W., Cannon, J.P., Dishaw, L.J., 2005. Reconstructing immune phylogeny: new perspectives. Nat Rev Immunol 5, 866-879.

Liu, Q., Zhou, Y.H., Yang, Z.Q., 2016. The cytokine storm of severe influenza and development of immunomodulatory therapy. Cellular & molecular immunology 13, 3-10.

Luheshi, G., Rothwell, N., 1996. Cytokines and fever. International archives of allergy and immunology 109, 301-307.

Maggi, E., Vultaggio, A., Matucci, A., 2011. Acute infusion reactions induced by monoclonal antibody therapy. Expert Rev Clin Immunol 7, 55-63.

Marsh, C.B., Gadek, J.E., Kindt, G.C., Moore, S.A., Wewers, M.D., 1995. Monocyte Fc gamma receptor cross-linking induces IL-8 production. J Immunol 155, 3161-3167.

Maude, S.L., Barrett, D., Teachey, D.T., Grupp, S.A., 2014. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer journal 20, 119-122.

Medzhitov, R., 2013. Pattern recognition theory and the launch of modern innate immunity. J Immunol 191, 4473-4474.

Mimoto, F., Katada, H., Kadono, S., Igawa, T., Kuramochi, T., Muraoka, M., Wada, Y., Haraya, T., Miyazaki, T., Hattori, K., 2013. Engineered antibody Fc variant with selectively enhanced FcγRIIb binding over both FcγRIIaR131 and FcγRIIaH131. Protein Eng Des Sel 26, 589-598.

Molema, G., Tervaert, J.W., Kroesen, B.J., Helfrich, W., Meijer, D.K., de Leij, L.F., 2000. CD3 directed bispecific antibodies induce increased lymphocyte-endothelial cell interactions in vitro. British journal of cancer 82, 472-479.

Moreau, T., Coles, A., Wing, M., Isaacs, J., Hale, G., Waldmann, H., Compston, A., 1996. Transient increase in symptoms associated with cytokine release in patients with multiple sclerosis. Brain 119 ( Pt 1), 225-237.

Nagele, V., Kratzer, A., Zugmaier, G., Holland, C., Hijazi, Y., Topp, M.S., Gokbuget, N., Baeuerle, P.A., Kufer, P., Wolf, A., Klinger, M., 2017. Changes in clinical laboratory parameters and pharmacodynamic markers in response to blinatumomab treatment of patients with relapsed/refractory ALL. Experimental hematology & oncology 6, 14.

Nguyen, D.H., Hurtado-Ziola, N., Gagneux, P., Varki, A., 2006. Loss of Siglec expression on T lymphocytes during human evolution. Proc Natl Acad Sci U S A 103, 7765-7770.

O'Shea, J.J., Murray, P.J., 2008. Cytokine signaling modules in inflammatory responses. Immunity 28, 477-487.

Pangalis, G.A., Dimopoulou, M.N., Angelopoulou, M.K., Tsekouras, C., Vassilakopoulos, T.P., Vaiopoulos, G., Siakantaris, M.P., 2001. Campath-1H (anti-CD52) monoclonal antibody therapy in lymphoproliferative disorders. Med Oncol 18, 99-107.

Pilia, G., Hughes-Benzie, R.M., MacKenzie, A., Baybayan, P., Chen, E.Y., Huber, R., Neri, G., Cao, A., Forabosco, A., Schlessinger, D., 1996. Mutations in GPC3, a glypican gene, cause the Simpson-Golabi-Behmel overgrowth syndrome. Nature genetics 12, 241-247.

Piquette, C.A., Robinson-Hill, R., Webster, R.O., 1994. Human monocyte chemotaxis to complementderived chemotaxins is enhanced by Gc-globulin. J Leukoc Biol 55, 349-354. Radtke, F., MacDonald, H.R., Tacchini-Cottier, F., 2013. Regulation of innate and adaptive immunity by Notch. Nat Rev Immunol 13, 427-437.

Romer, P.S., Berr, S., Avota, E., Na, S.Y., 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, 6772-6782.

Saber, H., Del Valle, P., Ricks, T.K., Leighton, J.K., 2017. An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection. Regulatory toxicology and pharmacology : RTP 90, 144-152.

Saber, H., Gudi, R., Manning, M., Wearne, E., Leighton, J.K., 2016. An FDA oncology analysis of immune activating products and first-in-human dose selection. Regulatory toxicology and pharmacology : RTP 81, 448-456.

Sandilands, G.P., Wilson, M., Huser, C., Jolly, L., Sands, W.A., McSharry, C., 2010. Were monocytes responsible for initiating the cytokine storm in the TGN1412 clinical trial tragedy? Clin Exp Immunol 162, 516-527.

Schrezenmeier, E., Jayne, D., Dorner, T., 2018. Targeting B Cells and Plasma Cells in Glomerular Diseases: Translational Perspectives. Journal of the American Society of Nephrology : JASN 29, 741-758.

Schutte, R.J., Parisi-Amon, A., Reichert, W.M., 2009. Cytokine profiling using monocytes/macrophages cultured on common biomaterials with a range of surface chemistries. Journal of biomedical materials research. Part A 88, 128-139.

Seimetz, D., Lindhofer, H., Bokemeyer, C., 2010. Development and approval of the trifunctional antibody catumaxomab (anti-EpCAM x anti-CD3) as a targeted cancer immunotherapy. Cancer treatment reviews 36, 458-467.

Shimabukuro-Vornhagen, A., Godel, P., Subklewe, M., Stemmler, H.J., Schlosser, H.A., Schlaak, M., Kochanek, M., Boll, B., von Bergwelt-Baildon, M.S., 2018. Cytokine release syndrome. Journal for immunotherapy of cancer 6, 56.

Shiraiwa, H., Narita, A., Kamata-Sakurai, M., Ishiguro, T., Sano, Y., Hironiwa, N., Tsushima, T., Segawa, H., Tsunenari, T., Ikeda, Y., Kayukawa, Y., Noguchi, M., Wakabayashi, T., Sakamoto, A., Konishi, H., Kuramochi, T., Endo, M., Hattori, K., Nezu, J., Igawa, T., 2019. Engineering a bispecific antibody with a common light chain: Identification and optimization of an antiCD3 epsilon and anti-GPC3 bispecific antibody, ERY974. Methods 154, 10-20.

Srivastava, R.K., Dar, H.Y., Mishra, P.K., 2018. Immunoporosis: Immunology of Osteoporosis-Role of T Cells. Frontiers in immunology 9, 657.

Stebbings, R., Eastwood, D., Poole, S., Thorpe, R., 2013. After TGN1412: recent developments in cytokine release assays. J Immunotoxicol 10, 75-82.

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, S.J., Bristow, A., Wadhwa, M., Thorpe, R., Poole, S., 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, 3325-3331.

Stephenson, J.J., Gregory, C., Burris, H., Larson, T., Verma, U., Cohn, A., Crawford, J., Cohen, R.B., Martin, J., Lum, P., Yang, X., Amado, R.G., 2009. An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. Clinical colorectal cancer 8, 29-37.

Strome, S.E., Sausville, E.A., Mann, D., 2007. A mechanistic perspective of monoclonal antibodies in cancer therapy beyond target-related effects. Oncologist 12, 1084-1095.

Suntharalingam, G., Perry, M.R., Ward, S., Brett, S.J., Castello-Cortes, A., Brunner, M.D., Panoskaltsis, N., 2006. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 355, 1018-1028.

Tabares, P., Berr, S., Romer, P.S., Chuvpilo, S., Matskevich, A.A., Tyrsin, D., Fedotov, Y., Einsele, H., Tony, H.P., Hunig, T., 2014. Human regulatory T cells are selectively activated by low-dose application of the CD28 superagonist TGN1412/TAB08. Eur J Immunol 44, 1225-1236.

Tang, D., Kang, R., Coyne, C.B., Zeh, H.J., Lotze, M.T., 2012. PAMPs and DAMPs: signal 0s that spur autophagy and immunity. Immunol Rev 249, 158-175.

Thorpe, S.J., Stebbings, R., Findlay, L., Eastwood, D., Poole, S., Thorpe, R., 2013. How predictive are in vitro assays for cytokine release syndrome in vivo? A comparison of methods reveals worrying differences in sensitivity and frequency of response. Cytokine 64, 471-472.

Tisoncik, J.R., Korth, M.J., Simmons, C.P., Farrar, J., Martin, T.R., Katze, M.G., 2012. Into the eye of the cytokine storm. Microbiology and molecular biology reviews : MMBR 76, 16-32.

Tkach, K., Writer, S., 2015. TGN1412: THE NEXT GENERATION. Biocentury Innovations, November 5

Topp, M.S., Kufer, P., Gokbuget, N., Goebeler, M., Klinger, M., Neumann, S., Horst, H.A., Raff, T., Viardot, A., Schmid, M., Stelljes, M., Schaich, M., Degenhard, E., Kohne-Volland, R., Bruggemann, M., Ottmann, O., Pfeifer, H., Burmeister, T., Nagorsen, D., Schmidt, M., Lutterbuese, R., Reinhardt, C., Baeuerle, P.A., Kneba, M., Einsele, H., Riethmuller, G., Hoelzer, D., Zugmaier, G., Bargou, R.C., 2011. Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemiafree survival. J Clin Oncol 29, 2493-2498.

Tsiantoulas, D., Diehl, C.J., Witztum, J.L., Binder, C.J., 2014. B cells and humoral immunity in atherosclerosis. Circulation research 114, 1743-1756.

Tyrsin, D., Chuvpilo, S., Matskevich, A., Nemenov, D., Römer, P.S., Tabares, P., Hünig, T., 2016. From TGN1412 to TAB08: the return of CD28 superagonist therapy to clinical development for the treatment of rheumatoid arthritis. Clinical and experimental rheumatology 34, S45-S48.

Van Gerven, J., Bonelli, M., 2018. Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. Br J Clin Pharmacol 84, 1401-1409.

Van Linthout, S., Miteva, K., Tschope, C., 2014. Crosstalk between fibroblasts and inflammatory cells. Cardiovasc Res 102, 258-269.

Van Spriel, A.B., van Ojik, H.H., van De Winkel, J.G., 2000. Immunotherapeutic perspective for bispecific antibodies. Immunology today 21, 391-397.

Vessillier, S., Eastwood, D., Fox, B., Sathish, J., Sethu, S., Dougall, T., Thorpe, S.J., 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.

Vogelpoel, L.T., Baeten, D.L., de Jong, E.C., den Dunnen, J., 2015. Control of cytokine production by human fc gamma receptors: implications for pathogen defense and autoimmunity. Frontiers in immunology 6, 79.

Waibler, Z., Sender, L.Y., Merten, C., Hartig, R., Kliche, S., Gunzer, M., Reichardt, P., Kalinke, U., Schraven, B., 2008. Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies. PLoS ONE 3, e1708.

Wang, H., Ma, S., 2008. The cytokine storm and factors determining the sequence and severity of organ dysfunction in multiple organ dysfunction syndrome. Am J Emerg Med 26, 711-715.

Ward, P.A., Cochrane, C.G., Mueller-Eberhard, H.J., 1965. The Role of Serum Complement in Chemotaxis of Leukocytes in Vitro. J Exp Med 122, 327-346.

Warncke, M., Calzascia, T., Coulot, M., Balke, N., Touil, R., Kolbinger, F., Heusser, C., 2012. Different adaptations of IgG effector function in human and nonhuman primates and implications for therapeutic antibody treatment. J Immunol 188, 4405-4411.

Wilson, M., Seymour, R., Henderson, B., 1998. Bacterial perturbation of cytokine networks. Infect Immun 66, 2401-2409.

Wing, M., 2008. Monoclonal antibody first dose cytokine release syndromes-mechanisms and prediction. J Immunotoxicol 5, 11-15.

Wing, M.G., Moreau, T., Greenwood, J., Smith, R.M., Hale, G., Isaacs, J., Waldmann, H., Lachmann, P.J., 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, 2819-2826.

Wing, M.G., Waldmann, H., Isaacs, J., Compston, D.A., Hale, G., 1995. Ex-vivo whole blood cultures for predicting cytokine-release syndrome: dependence on target antigen and antibody isotype. Ther Immunol 2, 183-190.

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, 828-837.

Wolf, B., Morgan, H., Brennan, F., Krieg, J., Gani, Z., Jones, S., Kiessling, A., 2013. Response to the letter to the editor by Susan Thorpe et al.: how predictive are in vitro assays for cytokine release syndrome in vivo? A comparison of methods reveals worrying differences in sensitivity and frequency of response. Cytokine 64, 473-475; discussion 476.

Wu, J., Fu, J., Zhang, M., Liu, D., 2015. Blinatumomab: a bispecific T cell engager (BiTE) antibody against CD19/CD3 for refractory acute lymphoid leukemia. Journal of hematology & oncology 8, 104.

Yuraszeck, T., Kasichayanula, S., Benjamin, J.E., 2017. Translation and Clinical Development of Bispecific T-cell Engaging Antibodies for Cancer Treatment. Clin Pharmacol Ther 101, 634-645.

Zhu, Z.W., Friess, H., Wang, L., Abou-Shady, M., Zimmermann, A., Lander, A.D., Korc, M., Kleeff, J., Buchler, M.W., 2001. Enhanced glypican-3 expression differentiates the majority of hepatocellular carcinomas from benign hepatic disorders. Gut 48, 558-564.

参考文献をもっと見る

全国の大学の
卒論・修論・学位論文

一発検索!

この論文の関連論文を見る