摘要
嵌合抗原受体T淋巴细胞(CAR-T)在淋巴造血系统恶性肿瘤,如B淋巴细胞白血病、B细胞淋巴瘤和多发性骨髓瘤等的治疗中展现出非常有吸引力的治疗前景。目前有多个课题申请人向中国国家药品监督管理局药品审评中心提交新药临床试验申请,其中很多CAR-T细胞临床试验课题在受试者筛选、疗效预后指标、风险控制等方面存在共性问题,可能影响受试者的安全性和疗效判断。药品审评中心通过总结国内外临床试验设计方面的经验并与国内临床专家交流探讨,对上述共性问题形成了若干考虑,供申办方或研究者开展药品注册临床试验时参考。
Chimeric antigen receptor(CAR) T lymphocyte has shown attractive prospects in the treatment of lymphohematopoietic malignancies including B-cell lymphoblastic leukemia, B-cell lymphoma and multiple myeloma. Many applicants have submitted investigational new drug(IND) applications to Center for Drug Evaluation of National Medical Products Ggency, however, many of the INDs have problems in patient selection, prognostic indicators and risk management, etc, which might hinder the evaluation of the safety and efficacy of CAR-T cells. Thus, we made some suggestions on the above-mentioned problems through summarizing clinical experience and communicating with domestic clinical experts, which the sponsors and researchers can refer to when conducting CAR-T cell clinical trials for registration.
作者
高建超
黄云虹
王洪航
王卉呈
潘建红
高晨燕
GAO Jianchao;HUANG Yunhong;WANG Honghang;WANG Huicheng;PAN Jianhong;GAO Chenyan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国肿瘤生物治疗杂志》
CAS
CSCD
北大核心
2019年第8期833-836,共4页
Chinese Journal of Cancer Biotherapy
关键词
嵌合抗原受体T淋巴细胞
淋巴造血系统恶性肿瘤
药品注册临床试验
chimeric antigen receptor T lymphocyte(CAR-T)
lymphohematopoietic malignancies
clinical trials for drug registration
