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对于高级子宫内膜癌的TIL的制造和抗瘤活动的可行性

Yongliang Zhang¹, Kathleen N Moore², Amir A Jazaeri³

¹Iovance Biotherapeutics, Inc., San Carlos, CA 94070, USA.

International journal of molecular sciences

|August 14, 2025

概括

从子宫内膜癌 (EC) 瘤中制造瘤透淋巴细胞 (TIL) 是可行的,使用Gen2过程. 这支持TIL细胞疗法在晚期EC患者的潜力.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
细胞疗法细胞疗法

背景情况:

Lifileucel是一种已批准的瘤透淋巴细胞 (TIL) 治疗晚期黑色素瘤的疗法,对其他固体瘤有潜力.
子宫内膜癌 (EC) 是探索新型治疗策略的一个重要领域.

研究的目的:

评估从子宫内膜癌 (EC) 瘤中制造TIL的可行性.
评估Iovance专有22天的Gen2制造工艺的有效性,用于EC衍生的TIL.

主要方法:

处理了11个EC瘤样本在研究规模和4个在完整规模.
关键制造参数的评估:TIL产量,活力,免疫表型,T细胞受体克隆性和细胞毒性活性.
试验室试验包括自身瘤刺激和有机杀死试验,以评估T细胞功能和抗瘤活性.

主要成果:

91%的研究规模样本 (10/11) 产生了>1 × 10^9可行的TIL,中位数产量为1.1 × 10^10细胞和82.8%的可行性.
所有的全尺寸样本都满足了总可活细胞计数 (TVC) 和可活性的预先规定的目标.
制造过程保持了对瘤反应的T细胞克隆,显示功能反应 (例如,细胞因子的产生) 和体外抗瘤活性.

结论:

使用Gen2制造工艺,可以从EC瘤中进行ex vivoTIL扩张.
这些发现提供了一个强有力的理由,在晚期EC患者中调查lifileucel.
根据这项可行性研究,开始II期临床试验IOV-END-201 (NCT06481592).

关键词:

免疫疗法免疫疗法不匹配的维修维修不匹配的维修透到瘤中的淋巴细胞这是子宫瘤.

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