嵌合抗原受体T细胞在软琼脂中克隆形成能力及体外致瘤性初探

doi:10.19803/j.1672-8629.2022.08.05

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (8): 836-838.
DOI: 10.19803/j.1672-8629.2022.08.05

• CAR-T 细胞非临床安全性研究与评价专栏 • 上一篇下一篇

嵌合抗原受体T细胞在软琼脂中克隆形成能力及体外致瘤性初探

黄瑛, 文海若^Δ, 侯田田, 霍艳, 王三龙^#, 耿兴超^*

中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京 100176

收稿日期:2022-04-27 出版日期:2022-08-15 发布日期:2022-08-15
通讯作者: ^*耿兴超,男,博士,研究员,药理毒理。E-mail：gengxch@nifdc.org.cn;^#为共同通信作者。
作者简介:黄瑛,女,博士,副研究员,药理毒理。^Δ为并列第一作者。
基金资助:
国家重点研发计划课题（2021YFA1101602）; 中国科学院战略先导科技专项（XDA1604050202）

Cloning ability of CAR-T cells in soft agar and tumorigenicity in vitro

HUANG Ying, WEN Hairuo^Δ, HOU Tiantian, HUO Yan, WANG Sanlong^#, GENG Xingchao^*

National Center for Safety evaluation of Drugs, National Institutes for Food and Drug Control, Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs, Beijing 100176, China

Received:2022-04-27 Online:2022-08-15 Published:2022-08-15

摘要/Abstract

摘要： 目的研究嵌合抗原受体T（chimeric antigen receptor T, CAR-T）细胞产品在软琼脂中形成克隆的可能性,从而评价其体外致瘤性,为其临床应用提供安全性依据。方法采用6孔板固态培养法,按不同密度（每孔1 000~5 000个）将CAR-T细胞与软琼脂混合铺板,同时设立Hela细胞为阳性对照,计数克隆形成率。结果空白对照组及受试物低（每孔1 000个）、中（每孔2 000个）、高（每孔5 000个）剂量组在培养后14 d内均未见细胞集落产生。阳性对照组14 d时有细胞集落出现。结论 CAR-T细胞体外培养不具有软琼脂克隆形成能力,利用软琼脂克隆形成实验可初步考察CAR-T细胞的体外致瘤性。

关键词: 嵌合抗原受体T细胞, 致瘤性, 软琼脂克隆, 非临床研究, 安全性

Abstract: Objective To study whether CAR-T cells formed clones in soft agar, so as to evaluate its tumorigenicity in vitro and to provide safety data for future clinical use. Methods CAR-T cells were mixed with soft agar at different densities (1 000 ~ 5 000 per well) on 6-well culturing plates. Hela cells were set as positive control to count the clone formation rate. Results There were no cell colonies in the control group and the low (1 000 per well), medium (2 000 per well) and high dose groups (5 000 per well) within 14 days after culture. There were cell colonies in the positive control group at 14 days. Conclusion CAR-T cells do not have the ability to form soft agar clones in vitro . The tumorigenicity of CAR-T cells in vitro can be preliminarily investigated by using soft agar clone formation assay.

Key words: chimeric antigen receptor T (CAR-T) cells, tumorigenicity, soft agar cloning, nonclinical research, safety

中图分类号:

R979.1

黄瑛, 文海若, 侯田田, 霍艳, 王三龙, 耿兴超. 嵌合抗原受体T细胞在软琼脂中克隆形成能力及体外致瘤性初探[J]. 中国药物警戒, 2022, 19(8): 836-838.

HUANG Ying, WEN Hairuo, HOU Tiantian, HUO Yan, WANG Sanlong, GENG Xingchao. Cloning ability of CAR-T cells in soft agar and tumorigenicity in vitro[J]. Chinese Journal of Pharmacovigilance, 2022, 19(8): 836-838.

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嵌合抗原受体T细胞在软琼脂中克隆形成能力及体外致瘤性初探

Cloning ability of CAR-T cells in soft agar and tumorigenicity in vitro

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