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在欧盟加速工程T细胞疗法的发展:研究多种产品版本的现有监管框架和T2EVOLVE建议

Delphine Ammar¹, Inga Schapitz², Maik Luu³

¹Regulatory Affairs, Astellas Pharma B.V., Leiden, Netherlands.

Frontiers in immunology

|December 11, 2023

概括

本文探讨了监管策略,以加快癌症先进细胞疗法的发展. 它的重点是使用现有的欧盟框架来进行代学习和跨产品版本的数据推断.

科学领域:

细胞免疫疗法细胞免疫疗法
监管科学是一种监管科学.
瘤学药物开发研究

背景情况:

先进治疗药物 (ATMP) 对于治疗有限选择的危及生命的癌症至关重要.
目前的监管方法需要不断评估和调整,以满足创新疗法的需求.
科学和基于风险的策略对于管理早期临床研究和灵活制造至关重要.

研究的目的:

探索在欧盟监管框架内加速开发CAR和TCR工程T细胞疗法的机会.
促进基于平台技术的不同产品版本的代和自适应式学习方法.
确定简化监管提交和优化临床研究的方法.

主要方法:

对ATMPs现有的欧盟监管框架的分析.
探索科学和基于风险的产品开发方法.
在具有相似设计元素的产品版本中利用代和自适应学习.

主要成果:

有机会通过在产品版本中推断数据来简化监管提交.
一种代和适应式的学习方法可以减少对重复研究的需求.
灵活的制造模式可以与降低风险保持平衡.

结论:

"T2EVOLVE"倡议建议利用欧盟的监管框架来加速ATMP的发展.
代学习和数据推断是优化临床研究和提交的关键.
对于CAR/TCR T细胞疗法所讨论的概念可能适用于其他工程细胞疗法.

关键词:

先进疗法药物 (ATMP) 是指先进疗法药物.临床发展临床发展工程T细胞疗法工程T细胞疗法有多个候选产品.父母-子女的方法.

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