摘要
嵌合抗原受体T细胞(CAR-T)疗法在血液肿瘤治疗中已取得显著疗效,且在难治性自身免疫性疾病领域也积累了一定的研究证据,有望成为这些疾病治疗中具有潜力的创新性治疗方法。基于现有的研究数据和临床经验,国家皮肤与免疫疾病临床医学研究中心与中国医师协会风湿免疫科医师分联合牵头制定了这一共识。该共识针对系统性红斑狼疮、系统性硬化症、特发性炎性肌病等自身免疫性疾病,规范了CAR-T细胞治疗在作为试验性治疗或同情用药的应用,包括患者筛选标准、治疗路径与方案设计、细胞制备与输注过程中的不良反应监测与处理、疗效评估指标、长期随访管理策略及复发后治疗选择等方面。共识特别强调了由风湿科医师牵头,多学科团队的协作,旨在提升CAR-T疗法的安全性与疗效,指导临床医生开展规范化的试验性治疗和同情用药,为难治性自身免疫病患者带来新的希望。
The chimeric antigen receptor T(CAR-T)cell therapy has demonstrated remarkable efficacy in the treatment of hematologic malignancies and has also accumulated substantial research evidence in the field of refractory autoimmune diseases,showing potential as an innovative therapeutic approach for these conditions.Based on existing research data and clinical experience,the National Clinical Research Center for Dermatology and Immunological Diseases and Rheumatology and Immunology Physicians Branch of Chinese Medical Doctor Association have jointly led the development of this consensus.This consensus provides guidelines for the use of CAR-T cell therapy as an experimental treatment or compassionate use in autoimmune diseases such as systemic lupus erythematosus,systemic sclerosis,and idiopathic inflammatory myopathies.It covers aspects such as patient selection criteria,treatment pathways and regimen design,monitoring and management of adverse reactions during cell preparation and infusion,efficacy evaluation metrics,long-term follow-up strategies,and treatment options after relapse.The consensus particularly emphasizes the leadership of rheumatologists and the collaboration of multidisciplinary teams,aiming to enhance the safety and efficacy of CAR-T therapy,to guide clinicians in conducting standardized experimental treatments and compassionate use,and to offer new hope for patients with refractory autoimmune diseases.
作者
国家皮肤与免疫疾病临床医学研究中心
中国医师协会风湿免疫科医师分会
徐沪济
曾小峰
王晓冰
田新平
戴冽
National Clinical Research Center for Dermatology and Immunological Diseases;Rheumatology and Immunology Physicians Branch of Chinese Medical Doctor Association;Xu Huji;Zeng Xiaofeng(不详;Department of Rheumatology and Immunology,Shanghai Changzheng Hospital,Naval Medical University,Shanghai 200003,China;Department of Rheumatology and Immunology,Peking Union Medical College Hospital,Beijing 100730,China)
出处
《中华风湿病学杂志》
2025年第6期469-480,共12页
Chinese Journal of Rheumatology
基金
国家重点研发计划项目(2024YFC2510300,2022YFF1203106)
上海市协同创新集群(2024CXJQ01)
中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-005)
中央高水平医院临床科研业务费资助(2022-PUMCH-D-009)。
关键词
嵌合抗原受体T细胞
自身免疫病
复发难治性
风湿免疫
风湿病
专家共识
Chimeric antigen receptor T cells
Autoimmune diseases,refractory
Rheumatology and Immunology
Rheumatic diseases
Expert consensus
