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杜尔瓦卢马布 (抗PD-L1) 联合莱纳利多米德在复发性/耐药性皮肤T细胞淋巴瘤的第一阶段试验

Christiane Querfeld^1,2,3,4, Joycelynne Palmer^4,5,6, Zhen Han^2,4

¹Division of Dermatology, City of Hope, Duarte, CA.

|February 14, 2025

概括

这项研究结合了杜尔瓦卢马布和莱纳利多米德治疗晚期皮肤T细胞淋巴瘤 (CTCL). 该组合证明了安全性和临床活性,在耐火性CTCL患者中显示出有希望的响应率和持久的响应.

科学领域:

在瘤学瘤学.
免疫学免疫学免疫学
临床试验临床试验

背景情况:

皮肤T细胞淋巴瘤 (CTCL) 是T细胞的恶性瘤.
编程细胞死亡1/编程细胞死亡配体1 (PD-1/PD-L1) 阻断 (杜尔瓦卢马布) 可以恢复抗瘤免疫力.
列纳利多米德是一种口服免疫调节剂,在CTCL中具有活性,可以增强PD-1/PD-L1阻塞.

研究的目的:

评估在耐火性/高级CTCL患者中结合杜尔瓦卢马布和莱纳利多米德的安全性和耐受性.
为了确定 lenalidomide与durvalumab的最大耐受剂量 (MTD) 和推的第二阶段剂量 (RP2D).
研究瘤微环境 (TME) 的疗效和影响.

主要方法:

进行了1/2期临床试验.
患者接受了杜尔瓦卢马布,并增加了莱纳利多米德的剂量.
评估了安全性,耐受性,MTD,RP2D,疗效和TME变化.

主要成果:

没有观察到严重的不良事件 (AE) 或剂量限制性毒性 (DLT).
剂量水平3被确定为RP2D.
最好的整体反应率为58.3%,皮肤反应率为75%. 响应的平均持续时间为25.5个月. 免疫特征可能预测反应.

结论:

杜尔瓦卢马布和莱纳利多米德的组合在耐火性/高级CTCL的患者中是安全的和可以容忍的.
这种组合显示出显著的临床活性和持久的反应.
对预测性免疫特征和TME变化的进一步调查是有必要的.

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