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治疗实体瘤的T细胞相关疗法现状及进展

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  • 1泓惠医药科技(北京)有限责任公司研发部, 北京 100040; 2四川大学人权法律研究中心,成都 610207

网络出版日期: 2026-08-11

Current status and progress of T cell-based therapies for solid tumors

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  • 1 Department of Research and Development, Honghui Pharmaceutical Technology (Beijing) Co., Ltd., Beijing 100040, China;2 Human Rights Law Research Center, Sichuan University, Chengdu 610207, China

Online published: 2026-08-11

摘要

T细胞介导的抗肿瘤免疫应答在实体瘤治疗中具有核心地位。近年来,围绕T细胞功能增强、过继性T细胞治疗、工程化抗原识别,以及内源性T细胞重定向等技术路径,多种T细胞相关疗法在实体瘤领域取得临床与监管进展。此文综述当前实体瘤T细胞相关疗法的主要技术路径及代表性证据,重点涵盖肿瘤浸润性淋巴细胞疗法、T细胞受体工程化T细胞疗法、T细胞受体类CD3 T细胞衔接器、嵌合抗原受体T细胞疗法,以及抗体类CD3 T细胞衔接器。基于已获批、重新获得上市许可或处于关键验证阶段的代表性产品,此文比较不同技术路径在实体瘤中的临床转化模式,并讨论其在人群覆盖、安全性管理、制造、可及性和证据成熟度等方面的结构性限制。总体而言,精准人群定位、免疫相关毒性的可管理性,以及制造与供给体系的成熟度,将成为决定相关疗法能否实现可持续临床转化的关键因素。

本文引用格式

樊凤辉, 乔娟 . 治疗实体瘤的T细胞相关疗法现状及进展[J]. 国际生物制品学杂志, 2026 , 49(4) : 284 -291 . DOI: 10.3760/cma.j.cn311962-20251116-00085

Abstract

T cell-mediated antitumor immune responses play a central role in the treatment of solid tumors. In recent years, multiple T cell-based therapeutic strategies, involving the expansion and adoptive transfer of tumor-reactive T cells, the engineering of antigen recognition in transferred T cells, and the in vivo redirection of endogenous T cells, have achieved important clinical advances and regulatory milestones in solid tumors. This review summarizes the major technological approaches and representative evidence for T cell-based therapies for solid tumors, focusing on tumor-infiltrating lymphocyte therapy, T-cell receptor (TCR)-engineered T-cell therapy, TCR-based CD3 T-cell engagers, chimeric antigen receptor T-cell therapy, and antibody-based CD3 T-cell engagers. Based on products approved, re-approved, or under pivotal development, this review compares the clinical translation patterns of different modalities and highlights structural constraints in target population coverage, safety management, manufacturability, access, and evidence maturity. Overall, precise patient selection, manageable immune-related toxicities, and mature manufacturing and supply systems will be key determinants of sustainable clinical translation.
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