大多數(shù)單克隆抗體可誘導(dǎo)免疫反應(yīng)，免疫毒性是免疫調(diào)節(jié)類單克隆抗體主要擔(dān)心的毒性反應(yīng)。本文總結(jié)了單克隆抗體的免疫毒性特征、免疫毒性的相關(guān)因素，非臨床免疫毒性研究與評價的考慮要點(diǎn)。建議在臨床前研究階段應(yīng)根據(jù)單克隆抗體的作用特征，對藥物的免疫毒性進(jìn)行逐步分層研究，當(dāng)需要追加試驗(yàn)時，應(yīng)追加研究；還應(yīng)體內(nèi)外研究相結(jié)合，動物種屬和人體離體細(xì)胞相結(jié)合，多途徑進(jìn)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.