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TCR-T 细胞治疗临床试验概况

英文原题:The Landscape of Clinical Trials for TCR-T Cell Therapy.

查看英文原题

The Landscape of Clinical Trials for TCR-T Cell Therapy.

PubMed 2026/05/25(内容时间) Am J Clin Oncol Q4 · IF 1.8(JCR 2025)

研究概要

为明确TCR-T疗法的主要趋势、关键靶点和治疗适应症,本研究基于对Trialtrove数据库的严格筛选,系统总结了TCR-T靶向临床试验的总体格局,包括截至2026年4月1日前的260项试验。

中文摘要

T细胞受体工程化T细胞(TCR-T)疗法是一种创新的肿瘤免疫疗法。与CAR-T不同,TCR-T可识别MHC限制性抗原以靶向肿瘤特异性抗原,在实体瘤和血液系统恶性肿瘤中均具有独特优势。为明确TCR-T疗法的主要趋势、关键靶点和治疗适应证,本研究基于对Trialtrove数据库的严格筛选,系统总结了TCR-T靶向临床试验的格局,纳入截至2026年4月1日前的260项试验。采用描述性统计,按试验阶段、状态、地域分布、疾病适应证、主要靶点和研究药物进行分析。总体而言,TCR-T临床研究热度持续,以早期试验为主(I期和I/II期合计占88.85%);活跃试验(开放招募和计划开展)占51.92%,已终止试验比例也较高(21.92%)。从地域看,试验集中在美国和中国,两国是核心协作节点,区域合作网络呈明显地域聚集特征。疾病适应证方面,TCR-T更聚焦实体瘤,排名前三位的是未特指实体瘤、非小细胞肺癌和头颈癌。NY-ESO-1是最主要靶点,其次为MAGE-A4、KRAS、PRAME、HPV16 E6/E7和乙肝病毒表面抗原;letetresgene autoleucel和LioCyx-M004是研究最多的TCR-T产品。总体而言,TCR-T疗法是肿瘤免疫治疗中一个前景良好的领域,研究投入持续增加,临床开发不断推进。

展开英文摘要原文

T cell receptor-engineered T cell (TCR-T) therapy represents an innovative tumor immunotherapy. Distinct from CAR-T, it recognizes MHC-restricted antigens to target tumor-specific antigens, exhibiting unique advantages for both solid and hematologic malignancies. To clarify the main trends, key targets, and therapeutic indications of TCR-T therapy, this study systematically summarizes the landscape of TCR-T-targeted clinical trials based on rigorous screening of the Trialtrove database, including 260 trials before April 1, 2026. Descriptive statistics were used to analyze the trials in terms of phase, status, distribution, disease indications, primary targets, and investigational drugs. Overall, TCR-T clinical research maintains sustained enthusiasm, dominated by early-phase trials (phase I and phase I/II, accounting for 88.85%), with active trials (open and planned) accounting for 51.92% and a considerable proportion of terminated trials (21.92%). Geographically, trials are concentrated in the United States and China, which serve as core collaboration nodes, with obvious geographical clustering characteristics in regional collaboration networks. In terms of disease indications, TCR-T therapy is more focused on solid tumors, with unspecified solid tumor, non-small cell lung cancer, and head/neck cancer as the top 3 indications. NY-ESO-1 is the most prominent target, followed by MAGE-A4, KRAS, PRAME, HPV16 E6/E7, and HBV surface antigen, with letetresgene autoleucel and LioCyx-M004 being the most investigated TCR-T products. Collectively, TCR-T therapy is a promising field in tumor immunotherapy with continuous research investment and advancing clinical progress.

论文信息

作者
Fan X、Yu T、Liao Q、Song Y、Liu G
单位
Department of General Surgery.
期刊
American journal of clinical oncology2026 May 25
原文标识
PubMed 42184246 · DOI 10.1097/COC.0000000000001335