A Safety and Efficacy Study of Transcription Activator-like Effector Nucleases and Clustered Regularly Interspaced Short Palindromic Repeat/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
This is an open-label and triple cohort study of the safety and efficacy of TALEN and CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial neoplasiaⅠwithout invasion.
详细描述
HPV persistent infection is the major causal factor of cervical intraepithelial neoplasia (CIN) and cervical cancer. The important roles of E6 and E7 playing in HPV-driven carcinogenesis make them attractive targets for therapeutic interventions. Previous evidences showed that using designated TALEN and CRISPR/Cas9 as genome editing tool could produce disruption of HPV16 and HPV18 E6/E7 DNA, significantly decreasing the expression of E6/E7, inducing cell apoptosis and inhibiting cell lines growth.
This study will evaluate the safety and efficacy of TALEN-HPV E6/E7 and CRISPR/Cas9-HPV E6/E7 in treating HPV Persistency and HPV-related Cervical Intraepithelial NeoplasiaⅠ
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented HPV16 or HPV18 infection.
- •Married and fertile, no fertility requirements.
- •Without administration of hormone in the last six months.
- •Subjects must be meet the ethical requirements and have signed informed consent.
排除标准
- •Pregnancy and breast feeding
- •Any bacterial vaginitis
- •Any Fungal vaginitis
- •Any sexually transmitted diseases
- •Active drug or alcohol abuse
- •Any HPV medications within the past 12 weeks
- •Allergy to active or non active ingredients in the study of drugs
- •Cardiac insufficiency
- •Liver and renal insufficiency
- •Hypertension and severe complications
- •Serious illness in past 30 days
- •Currently participating in another clinical trial or any prior gene therapy
结局指标
主要结局
Number of participants with Adverse Events
时间窗: 6 months
The primary objective of this Study is to evaluate the safety of therapeutic doses and the dosing regimen of TALEN and CRISPR/Cas9 plasmid.
次要结局
- Change of cervical histological results.(Baseline and 6 months.)
- Change of HPV16 or 18 DNA titers(Baseline, 3 and 6 months)
- Change of cervical cytological results.(Baseline, 3 and 6 months)
研究者
Hu Zheng
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University