Considerations on nonclinical studies for immunotoxicity of monoclonal antibodies / 药物评价研究

Most monoclonal antibodies (mAbs) can induce immune responses.For immunomodulatory mAbs,immunotoxicity is the major toxicity.This article summarizes the characteristics of immunotoxicity,the factors associated with immunotoxicity,and the general considerations of nonclinical studies and evaluations.Before the clinical trials,comprehensive nonclinical studies on immunotoxicityshould be step by step conductedbased on mAbs' characteristics.If needed,some additional studies should be conducted.Attention should be paid to combination of in vivo and in vitro studies,combination of animal species and humanex vivo cells,and multiple approaches for studies.