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非霍奇金淋巴瘤中的 CAR-T 细胞治疗:临床试验全景综述

英文原题:CAR-T cell therapy in non-Hodgkin lymphoma: a clinical trial landscape review.

查看英文原题

CAR-T cell therapy in non-Hodgkin lymphoma: a clinical trial landscape review.

PubMed 2026/05/08(内容时间) Front Immunol Q1 · IF 7(JCR 2025)

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研究概要

在学术创新和不断扩展的临床前认知推动下,NHL 领域的 CAR-T 疗法研发持续快速推进。

中文摘要

CAR-T 细胞疗法已成为部分非霍奇金淋巴瘤(NHL)亚型的重要治疗方式。尽管多种CAR-T 产品已显示显著临床活性,但整体临床开发格局仍高度异质,在试验设计、靶点选择、地域分布和终点优先级方面存在明显差异。对全球临床试验格局进行全面分析,对于理解当前进展并识别这一快速发展领域未满足的需求至关重要。

我们利用Trialtrove数据库,对NHL相关CAR-T 临床试验开展系统性格局分析。依据预设检索标准,检索截至2025年12月18日注册的干预性试验。按标准化纳入和排除标准筛选研究,并提取试验状态、阶段、地理位置、申办方类型、分子靶点和报告的临床终点等主要特征进行描述性分析。

最终分析纳入360项符合条件的临床试验。全球NHL CAR-T 临床试验格局表现为快速扩张,且主要聚焦早期开发。试验活动高度集中于少数国家,学术机构是临床研究的主要推动力量。CD19靶向CAR-T 疗法占据主导地位,但对其他靶点的探索也日益增多。报告的研究终点主要强调安全性和短期疗效,对持久临床结局的评估相对较少,反映出多数试验仍处于探索阶段。

在学术创新和不断扩展的临床前研究推动下,NHL CAR-T 疗法开发持续快速进展。然而,抗原逃逸、治疗持久性和试验设计方面的挑战仍然存在。未来进展需要整合下一代CAR工程策略、更广泛纳入长期临床终点,并与不断发展的监管和政策框架相协调,以支持可持续的临床转化。

展开英文摘要原文

Chimeric antigen receptor T cell (CAR-T) therapy has emerged as a transformative treatment modality for selected subtypes of non-Hodgkin lymphoma (NHL). While multiple CAR-T products have demonstrated remarkable clinical activity, the overall clinical development landscape remains heterogeneous, with substantial variation in trial design, target selection, geographic distribution, and endpoint prioritization. A comprehensive analysis of the global clinical trial landscape is essential to contextualize current progress and identify unmet needs in this rapidly evolving field.

We conducted a systematic landscape analysis of CAR-T-related clinical trials for NHL using the Trialtrove database. Interventional trials registered up to December 18, 2025, were retrieved using predefined search criteria. Eligible studies were screened according to standardized inclusion and exclusion criteria. Key trial characteristics, including trial status, phase, geographic location, sponsor type, molecular targets, and reported clinical endpoints, were extracted and analyzed descriptively.

A total of 360 eligible clinical trials were included in the final analysis. The global CAR-T clinical trial landscape in NHL is characterized by rapid expansion and a predominant focus on early-phase development. Trial activity is highly concentrated in a limited number of countries, with academic institutions serving as the primary drivers of clinical investigation. CD19-directed CAR-T therapies dominate the current landscape, although emerging diversification toward alternative targets is evident. Reported study endpoints largely emphasize safety and short-term efficacy, whereas durable clinical outcomes remain less frequently assessed, reflecting the exploratory nature of most trials.

CAR-T therapy development in NHL continues to advance rapidly, driven by academic innovation and expanding preclinical insights. However, persistent challenges related to antigen escape, treatment durability, and trial design remain. Future progress will require the integration of next-generation CAR engineering strategies, broader incorporation of long-term clinical endpoints, and alignment with evolving regulatory and policy frameworks to support sustainable clinical translation.

论文信息

作者
Wu J、Liao Y、Wang W、Zhang X
单位
Department of Gastroenterology, The First People's Hospital of Shuangliu District (West China Airport Hospital of Sichuan University), Chengdu, Sichuan, China.China
文献类型
系统综述
期刊
Frontiers in immunology2026
原文标识
PubMed 42183280 · DOI 10.3389/fimmu.2026.1820425