期刊
MOLECULAR THERAPY
卷 26, 期 1, 页码 280-288出版社
CELL PRESS
DOI: 10.1016/j.ymthe.2017.09.008
关键词
-
资金
- NHLBI [P40HL116242]
- Novartis
- Juno Therapeutics
- Cell Processing Section at the NIH Clinical Center
- Hematologic Malignancies section of the Pediatric Oncology Branch
- Intramural Research Program at the NIH
- [NCT01865617]
Exposure to replication-competent lentivirus (RCL) is a theoretical safety concern for individuals treated with lentiviral gene therapy. For certain ex vivo gene therapy applications, including cancer immunotherapy trials, RCL detection assays are used to screen the vector product as well as the vector-transduced cells. In this study, we reviewed T cell products screened for RCL using methodology developed in the National Gene Vector Biorepository. All trials utilized third-generation lentiviral vectors produced by transient transfection. Samples from 26 clinical trials totaling 460 transduced cell products from 375 subjects were evaluated. All cell products were negative for RCL. A total of 296 of the clinical trial participants were screened for RCL at least 1 month after infusion of the cell product. No research subject has shown evidence of RCL infection. These findings provide further evidence attesting to the safety of third-generation lentiviral vectors and that testing T cell products for RCL does not provide added value to screening the lentiviral vector product.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据