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中华细胞与干细胞杂志(电子版) ›› 2025, Vol. 15 ›› Issue (06) : 361 -367. doi: 10.3877/cma.j.issn.2095-1221.2025.06.006

综述

肿瘤浸润淋巴细胞治疗实体瘤及血液肿瘤的研究进展
韦丽娅, 肖扬()   
  1. 518067 深圳市前海蛇口自贸区医院血液内科
  • 收稿日期:2025-08-25 出版日期:2025-12-01
  • 通信作者: 肖扬
  • 基金资助:
    2023年南山区卫生健康局一般项目(NS2023047)

Progress in tumor-infiltrating lymphocytes therapy for solid and hematologic malignancies

Liya Wei, Yang Xiao()   

  1. Department of Hematology, Shenzhen Qianhai Shekou Pilot Free Trade Zone Hospital, Shenzhen 518067, China
  • Received:2025-08-25 Published:2025-12-01
  • Corresponding author: Yang Xiao
引用本文:

韦丽娅, 肖扬. 肿瘤浸润淋巴细胞治疗实体瘤及血液肿瘤的研究进展[J/OL]. 中华细胞与干细胞杂志(电子版), 2025, 15(06): 361-367.

Liya Wei, Yang Xiao. Progress in tumor-infiltrating lymphocytes therapy for solid and hematologic malignancies[J/OL]. Chinese Journal of Cell and Stem Cell(Electronic Edition), 2025, 15(06): 361-367.

近年来,免疫疗法在肿瘤治疗中进展迅速,其中免疫细胞的过继免疫治疗在实体瘤及血液肿瘤的治疗越来越受重视。肿瘤浸润淋巴细胞(TIL)是继淋巴因子激活杀伤细胞之后发现的一种新型免疫活性细胞,在不需要大量白细胞介素-2 (IL-2)诱导的情况下即可展现出很强的特异性和有效性。本文探讨TIL的生物学特点及临床应用的挑战,和其在实体瘤及血液肿瘤的研究进展,并展望未来的发展方向。

In recent years, immunotherapy has made remarkable advances in cancer treatment, with adoptive cellular immunotherapy gaining increasing attention in both solid and hematologic malignancies. Tumor-infiltrating lymphocytes (TIL), identified after lymphokine-activated killer cells, represent a novel population of immune-active cells that exhibit strong specificity and efficacy without the need for extensive interleukin-2 (IL-2) induction. This review summarizes the biological characteristics of TIL, highlights the challenges associated with their clinical application, examines recent advances in both solid and hematologic malignancies, and outlines potential future directions in the field.

表1 实体瘤肿瘤浸润淋巴细胞临床试验汇总表
表2 肿瘤浸润淋巴细胞中国临床试验注册项目
注册号 项目名称 机构名称 注册时间
ChiCTR2100044420 E/S (c)TIL (基因修饰的肿瘤浸润淋巴细胞)治疗恶性实体肿瘤安全性和有效性的临床研究 郑州大学第一附属医院 2021.03
ChiCTR2100045007 自体肿瘤浸润淋巴细胞(TIL)治疗转移/复发的晚期实体瘤的单中心、单臂Ⅰ期临床研究 徐州医科大学附属医院 2021.04
ChiCTR2100046175 自体肿瘤浸润淋巴细胞(TIL)联合PD-1单抗治疗复发/转移的非小细胞肺癌的单臂开放性临床研究 中国科学技术大学附属第一医院 2021.05
ChiCTR2100052853 肿瘤浸润淋巴细胞治疗晚期肺腺癌的安全性和疗效评估 复旦大学附属华东医院 2021.11
ChiCTR2100054761 自体肿瘤浸润淋巴细胞注射液(GT201)治疗转移/复发的晚期实体瘤的单中心、单臂Ⅰ期临床研究 浙江大学医学院附属第一医院 2021.12
ChiCTR2100054763 自体肿瘤浸润淋巴细胞(TIL)治疗转移/复发的晚期实体瘤的单中心、单臂Ⅰ期临床研究 苏州大学附属第一医院 2021.12
ChiCTR2200058937 一项开放、单臂、S (c)TIL (基因修饰的肿瘤浸润淋巴细胞)治疗妇科恶性肿瘤的安全性、药代动力学特征和有效性的Ⅱa期临床研究 中国医学科学院北京协和医院,妇科肿瘤中心 2022.04
ChiCTR2200063835 HS-IT101自体肿瘤浸润淋巴细胞(TIL)注射液治疗晚期实体瘤的安全性和有效性的临床研究 青岛大学附属医院 2022.09
表3 中国肿瘤浸润淋巴细胞ClinicalTrials.gov注册项目
注册号 研究题目 开始时间/状态
NCT06828328 基因编辑的GC203 TIL在胰腺导管腺癌中的研究 202502/招募
NCT06819280 自体肿瘤浸润淋巴细胞注射液(GT301)用于治疗晚期结直肠癌患者 202406/招募
NCT06703398 多中心、随机、对照、开放标签的Ⅱ期临床试验:自体肿瘤浸润淋巴细胞(GC101 TIL)用于晚期实体瘤患者 202412/招募
NCT06640582 TIL联合Pembrolizumab治疗包括神经胶质瘤和脑膜瘤在内的晚期脑癌 202410/招募
NCT06538012 TIL联合Pembrolizumab治疗晚期或转移性难治性肺癌 202408/招募
NCT06532812 TIL联合免疫治疗治疗晚期或转移性难治性乳腺癌 202408/招募
NCT06532799 TIL联合Pembrolizumab治疗晚期或转移性难治性胃癌和食管癌 202409/招募
NCT06530303 生物肿瘤浸润淋巴细胞联合免疫治疗结直肠癌 202409/招募
NCT06519669 自体肿瘤浸润淋巴细胞注射液(GT201)用于治疗晚期肺癌患者 202407/招募
NCT06491225 自体肿瘤浸润淋巴细胞(GTB-001注射液)用于治疗晚期肺腺癌患者 202407/招募
NCT06488950 TIL研究用于治疗晚期实体瘤 202304/招募
NCT06473961 自体GC101 TIL注射的Ⅰb期研究,用于治疗NSCLC 202410/招募
NCT06463522 自体肿瘤浸润淋巴细胞治疗晚期肝细胞癌的安全性和有效性研究 202407/招募
NCT06453057 自体肿瘤浸润淋巴细胞(GT307)用于治疗晚期实体瘤患者 202407/招募
NCT06375187 工程化肿瘤浸润淋巴细胞注射液(GC203 TIL)用于治疗晚期实体瘤 202405/招募
NCT06334783 TIL治疗晚期实体瘤患者 202305/招募
NCT06241781 自体肿瘤浸润淋巴细胞(GT101注射液)治疗复发宫颈癌的研究 202404/招募
NCT06145802 自体肿瘤浸润淋巴细胞注射液(GT316)用于治疗晚期实体瘤(妇科肿瘤)的临床研究 202303/招募
NCT06120712 自体GC101 TIL注射的Ⅰb期研究,用于治疗晚期黑色素瘤(MIZAR-002) 202311/招募
NCT06094426 自体肿瘤浸润淋巴细胞注射用于治疗晚期实体瘤 202302/招募
NCT06088472 TIL注射用于治疗转移性或复发性实体瘤 202104/完成
NCT06084299 使用肿瘤浸润淋巴细胞的免疫治疗用于治疗晚期肝癌患者 202005/招募
NCT05878028 L-TIL联合Tislelizumab治疗PD1抗体耐药的NSCLC 202209/招募
NCT05831033 自体肿瘤浸润淋巴细胞(TIL)治疗晚期实体瘤患者的安全性和有效性 202305/招募
NCT05729399 自体肿瘤浸润淋巴细胞注射液(GT201)治疗晚期实体瘤的临床研究 202209/招募
NCT05417750 自体肿瘤浸润淋巴细胞注射液(GC101 TIL)的Ⅰ期研究,用于治疗晚期恶性实体瘤 202207/招募
NCT05142475 TIL用于治疗晚期乳腺癌的研究 202111/招募
NCT05098184 TIL用于治疗晚期黑色素瘤的研究 202109/招募
NCT05098197 TIL用于治疗晚期肝胆胰肿瘤的研究 202109/招募
NCT05087745 TIL用于治疗晚期实体瘤的临床研究 202112/招募
NCT04960072 TIL用于治疗消化道肿瘤的研究 202106/完成
NCT04943913 TIL用于治疗脑胶质瘤的研究 202105/完成
NCT04842812 工程化TILs/CAR-TILs用于治疗晚期实体瘤 202101/招募
NCT04766320 TIL用于治疗妇科肿瘤的研究 202101/完成
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