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NK 细胞免疫治疗的临床试验格局与转化前景:基于 INFORMA 数据库的分析

英文原题:Clinical trial landscape and translational prospects of natural killer cell-based immunotherapy: an analysis based on the INFORMA database.

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Clinical trial landscape and translational prospects of natural killer cell-based immunotherapy: an analysis based on the INFORMA database.

PubMed 2026/08/07(内容时间) J Immunother Cancer Q1 · IF 11.7(JCR 2025)

研究概要

这些发现表明,正从概念验证性过继转移转向标准化、可基因编程的现货型平台。

中文摘要

自然杀伤(NK)细胞免疫疗法因其固有细胞毒性、异体应用潜力及适用于现货型生产,正成为日益重要的肿瘤治疗策略。我们分析了 INFORMA 数据库中的 287 项临床试验,考察 NK 细胞疗法在不同试验阶段、地区、适应证、联合方案、细胞来源、产品来源和工程化平台方面的全球发展情况。多数试验处于计划阶段或早期阶段,联合治疗比单药治疗更常见。美国、中国和韩国的临床研究最为活跃。血液系统恶性肿瘤仍是主要试验领域,同时肺癌、结直肠癌及其他实体瘤的研究显示出该疗法应用范围正在扩大。平台分析显示,异基因产品占主导地位,2020 年后 CAR 工程化 NK 细胞试验快速增长。这些发现表明,该领域正从概念验证性过继转移,转向标准化、可基因编程的现货型平台。当前主要挑战已从单纯证明生产可行性,转向实现持久的生物学活性。未来开发应针对持续性、肿瘤递送、微环境适应性及免疫逃逸等具体障碍,协调细胞工程、联合治疗药物、转化研究终点和生物标志物指导的患者选择。

展开英文摘要原文

Natural killer (NK) cell-based immunotherapy is an increasingly important cancer treatment strategy because of its innate cytotoxicity, allogeneic potential, and compatibility with off-the-shelf manufacturing. We analyzed 287 clinical trials identified in the INFORMA database to characterize the global development of NK-cell therapies across phases, regions, indications, combinations, cell sources, product origins, and engineering platforms. Most trials were planned or early-phase, and combination regimens were more frequent than monotherapy. The USA, China, and South Korea led clinical activity. Hematologic malignancies remained the principal testing ground, while lung, colorectal, and other solid tumors reflected broader expansion. Platform-level analysis showed a predominance of allogeneic products and rapid growth of CAR-engineered NK-cell trials after 2020. These findings indicate a transition from proof-of-concept adoptive transfer toward standardized, genetically programmable, off-the-shelf platforms. The principal challenge is shifting from manufacturing feasibility alone to durable biological activity. Future development should align cell engineering, combination partners, translational endpoints, and biomarker-guided patient selection with specific barriers involving persistence, tumor delivery, microenvironmental fitness, and immune escape.

论文信息

作者
Sun H、Zhang Y、Yuan Y、Liu D、Qiao J
第一作者单位
Department of Radiotherapy, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China.China
通讯作者单位
Department of Interventional Therapy, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China jhqdtxb@126.com.China
期刊
Journal for immunotherapy of cancer2026 Aug 7
原文标识
PubMed 42567562 · DOI 10.1136/jitc-2026-016348