Mechanism and preclinical evaluation of cytokine release syndrome induced by monoclonal antibodies
Monoclonal antibody drugs have broad therapeutic prospects in cancer,immune-related diseases,and other fields.With the accumulation of preclinical and clinical research data,people's understanding of their immunotoxicity has become deeper and deeper.Cytokine release syndrome(CRS)is a systemic inflammatory reaction that immune system is widely activated by various factors.Monoclonal antibodies can cause cytokine release by activating effector cells or non-effector cells,which seriously threatens the health of patients.Before clinical trials,the safety of monoclonal antibodies is evaluated by in vitro CRA and in vivo test.Although data from in vivo and in vitro tests can complement each other,clinical occurrence is usually not fully predicted,and preclinical prediction of the risk of CRS induced by monoclonal antibodies remains an issue to be solved.This paper reviewed the cytokine release syndrome induced by monoclonal antibody products from three aspects,including mechanisms,relevant regulations and preclinical evaluation methods of CRS,in order to provide new ideas for the preclinical safety evaluation strategies of monoclonal antibody products.