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在临床上可用的双特异性T细胞参与剂中对抗CD3抗体的表征

Hyeonmin Lee¹, Yonghee Lee², Junho Chung³

¹Department of Biochemistry and Molecular Biology, Seoul National University College of Medicine, Seoul, Republic of Korea; Interdisciplinary Program in Cancer Biology Major, Seoul National University College of Medicine, Seoul, Republic of Korea.

Seminars in hematology

|September 23, 2025

概括

针对CD3的双特异性T细胞受体 (TCE) 可以根据CDR序列分为六个家族. 莫苏尼图祖马布 (家族4) 呈现的不良事件较少,而一些TCE缺乏与非人类灵长类动物CD3的交叉反应,影响了临床前发展.

科学领域:

免疫学免疫学免疫学
在瘤学瘤学.
药理学药理学是指药理学的学科.

背景情况:

双特异性T细胞参与剂 (TCE) 是工程抗体,通过向T细胞和瘤抗原上的CD3来利用T细胞进行癌症治疗.
截至2025年7月,有10种双特异性TCE在临床上可用,具有不同的CD3结合抗体起源和序列.

研究的目的:

根据CD3结合抗体序列对临床可用的双特异性TCE进行分类.
研究CD3结合抗体家族,临床疗效,安全性概况和临床前交叉反应性之间的关系.

主要方法:

根据它们的互补性决定区域 (CDR) 的≥80%序列相同性,抗体被分为六个家族.
使用in silico表位预测来分析CD3结合部位.
对所有双特异性TCE进行了评估,与Cynomolgus子CD3ε的交叉反应性.

主要成果:

鉴定了6个CD3结合抗体家族,包括第1家族 (blinatumomab),第2家族 (5个抗体) 和第6家族 (tebentafusp).
莫苏尼图祖马布 (家族4) 显示了诸如细胞因子释放综合征 (CRS) 和神经毒性等不良事件的发生率较低.
八种双特异性TCE与Cynomolgus子CD3ε呈现交叉反应,与blinatumomab和tebentafusp不同.

结论:

CD3结合抗体序列的相似性定义了两种特异性TCEs的不同家族.
莫苏尼图祖马布独特的安全性需要进一步调查.
在一些双特异性TCE中缺乏交叉反应性,这对非人类灵长类动物临床前安全性和毒性研究提出了挑战.

关键词:

双特异性T细胞参与者 (双特异性TCE)这是一个CD3epsilon (CD3ε).这是一个CD3绑定域.细胞因子释放综合征 (CRS)在地图上绘制出地图的地图.两种物种的交叉反应性.

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