大多数单克隆抗体可诱导免疫反应，免疫毒性是免疫调节类单克隆抗体主要担心的毒性反应。本文总结了单克隆抗体的免疫毒性特征、免疫毒性的相关因素，非临床免疫毒性研究与评价的考虑要点。建议在临床前研究阶段应根据单克隆抗体的作用特征，对药物的免疫毒性进行逐步分层研究，当需要追加试验时，应追加研究；还应体内外研究相结合，动物种属和人体离体细胞相结合，多途径进行研究。

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.