Severalconsiderationsontherelatedissuesofclinicaltrialdesignofchimericantigen receptorT lymphocytes in the treatment of lymphohematopoietic malignancies
10.3872/j.issn.1007-385x.2019.08.001
- VernacularTitle:CAR-T细胞治疗淋巴造血系统恶性肿瘤临床试验设计相关问题的考虑
- Author:
GAO Jianchao
1
;
HUANG Yunhong
1
;
WANG Honghang
1
;
WANG Huicheng
1
;
PAN Jianhong
1
;
GAO Chenyan
1
Author Information
1. Center for Drug Evaluation, National Medical ProductsAdministration
- Publication Type:Journal Article
- Keywords:
chimeric antigen receptor T lymphocyte (CAR-T);
lymphohematopoietic malignancies;
clinical trials for drug registration
- From:
Chinese Journal of Cancer Biotherapy
2019;26(8):833-836
- CountryChina
- Language:Chinese
-
Abstract:
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.
- Full text:20190801.pdf
