Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412

Journal of Immunological Methods

Volumn 352, Issue 1-2, 2010, Pages 1-12

  Findlay, Lucy ^a   Eastwood, David ^a   Stebbings, Richard ^a   Sharp, Giles ^a   Mistry, Yogesh ^a   Ball, Christina ^a   Hood, John ^a   Thorpe, Robin ^a   Poole, Stephen ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

Immobilised antibody; Pro inflammatory cytokines; TGN1412; Therapeutic monoclonal antibodies

Indexed keywords

INTERLEUKIN 6; INTERLEUKIN 8; POLYPROPYLENE; POLYSTYRENE; TGN 1412; TUMOR NECROSIS FACTOR ALPHA;

ANTIBODY RESPONSE; AQUEOUS SOLUTION; ARTICLE; CELL CULTURE; CONTROLLED STUDY; CULTURE VESSEL; CYTOKINE RELEASE; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; HUMAN CELL; IMMOBILIZATION; IN VITRO STUDY; PERIPHERAL BLOOD MONONUCLEAR CELL; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING;

ANTIBODIES, MONOCLONAL; ANTIGENS, CD28; BINDING, COMPETITIVE; CELL PROLIFERATION; CELLS, CULTURED; DRUG EVALUATION; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOTHERAPY, ACTIVE; LEUKOCYTES, MONONUCLEAR; LYMPHOCYTE ACTIVATION; RECOMBINANT FUSION PROTEINS; TUMOR NECROSIS FACTOR-ALPHA;

EID: 71749108311     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2009.10.013     Document Type: Article

References (14)

1. Beyersdorf N., Hanke T., Kerkau T., and Hunig T. Superagonistic anti-CD28 antibodies: potent activators of regulatory T cells for the therapy of autoimmune diseases. Ann. Rheum. Dis. 64 (2005) 91
2. Chung C.H. Managing premedications and the risk for reactions to infusional monoclonal antibody therapy. Oncologist 13 (2008) 725
3. Expert Group on Phase One Clinical Trials: Final report. Expert Group on Phase One Clinical Trials (Chairman: Professor Gordon W. Duff) (2006). http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117 Accessed at http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117
4. Givan A.L., Fisher J.L., Waugh M., Ernstoff M.S., and Wallace P.K. A flow cytometric method to estimate the precursor frequencies of cells proliferating in response to specific antigens. J. Immunol. Methods 230 (1999) 99
5. Hanke T. Lessons from TGN1412. Lancet 368 (2006) 1569
6. Lin C.H., Kerkau T., Guntermann C., Trischler M., Beyersdorf N., Scheuring Y., Tony H.P., Kneitz C., Wilhelm M., Mueller P., Huenig T., and Hanke T. Superagonistic anti-CD28 antibody TGN1412 as a potential immunotherapeutic for the treatment of B cell chronic lymphocytic leukemia. ASH Annual Meeting Abstracts 104 (2004) 2519
7. Luhder F., Huang Y., Dennehy K.M., Guntermann C., Muller I., Winkler E., Kerkau T., Ikemizu S., Davis S.J., Hanke T., and Hunig T. Topological requirements and signaling properties of T cell-activating, anti-CD28 antibody superagonists. J. Exp. Med. 197 (2003) 955
8. Rodriguez-Palmero M., Franch A., Castell M., Pelegri C., Perez-Cano F.J., Kleinschnitz C., Stoll G., Hunig T., and Castellote C. Effective treatment of adjuvant arthritis with a stimulatory CD28-specific monoclonal antibody. J. Rheumatol. 33 (2006) 110
9. 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., and 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. 179 (2007) 3325
10. Suntharalingam G., Perry M.R., Ward S., Brett S.J., Castello-Cortes A., Brunner M.D., and Panoskaltsis N. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355 (2006) 1018
11. Tacke M., Hanke G., Hanke T., and Hunig T. CD28-mediated induction of proliferation in resting T cells in vitro and in vivo without engagement of the T cell receptor: evidence for functionally distinct forms of CD28. Eur. J. Immunol. 27 (1997) 239
12. TeGenero AG. TGN1412 Investigational Medicinal Product Dossier (2005). http://www.circare.org/foia5/tgn1412dossier.pdf Accessed at: http://www.circare.org/foia5/tgn1412dossier.pdf
13. TeGenero AG. TGN1412 investigator's brochure, Wurzburg, Germany (2005). http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117 Accessed at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117
14. Wing M.G., Waldmann H., Isaacs J., Compston D.A., and Hale G. Ex vivo whole blood cultures for predicting cytokine-release syndrome: dependence on target antigen and antibody isotype. Ther. Immunol. 2 (1995) 183