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Start Over Author "Paula Tabares" Journal clinical and experimental rheumatology
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1. From TGN1412 to TAB08: the return of CD28 superagonist therapy to clinical development for the treatment of rheumatoid arthritis

Author

Dmitry, Tyrsin, Sergey, Chuvpilo, Alexey, Matskevich, Daniil, Nemenov, Paula S, Römer, Paula, Tabares, and Thomas, Hünig

Subjects
Arthritis, Rheumatoid, Disease Models, Animal, CD28 Antigens, Antirheumatic Agents, Animals, Cytokines, Humans, Molecular Targeted Therapy, Antibodies, Monoclonal, Humanized, Lymphocyte Activation, Risk Assessment, T-Lymphocytes, Regulatory, Signal Transduction
Abstract

CD28 superagonists (CD28SA) are CD28-specific monoclonal antibodies which are able to activate T-cells without overt TCR engagement. In rodents, CD28SA efficiently activate regulatory T-cells and are therapeutically effective in multiple models of autoimmunity, inflammation and transplantation. However, a phase I study of the human CD28SA TGN1412 in 2006 resulted in a life-threatening cytokine storm. This brief review summarises preclinical work before and since the failed phase I trial with an emphasis on understanding the reasons why there had been no warning of toxicity, and how a novel assay paved the way for a new phase I, phase Ib (both completed), and an ongoing phase II study.

Published
2016

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