Safety Study of Transcription Activator-like Effector Nucleases T512 in HPV16-infected Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety-Number of participants with Adverse Events
研究概览
简要总结
This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
详细描述
Persistent infection with high-risk human papillomavirus (HPVs),especially types 16 and 18,may lead to cervical intraepithelial neoplasia(CIN).HPVs expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies showed that using designated TALENs (T27 and T512) targeted HPV16 E6 and E7 produced disruption of HPV16 E6 and E7 DNA, decreased the expression of E6 and E7 proteins, and induced cell apoptosis.
This study will evaluate the safety and efficacy of and T512 in treating HPV Persistency and HPV16-positive CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 infection and integration.
- •Married and fertile, no fertility requirements.
- •The cervical transformation zone was type I or II, and the biopsy results under colposcopy suggested SIL.
- •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
Safety-Number of participants with Adverse Events
时间窗: 6 months
Number of participants who report adverse events as a measure of safety
次要结局
- Number of dysplastic cells mearsured by ThinPrep Pap Test(Baseline, 3 and 6 months)
- Change of HPV16 DNA titers(Baseline, 3 and 6 months)
- Change of cervical histological results(Baseline and 6 months)
研究者
Ding Ma
Head of Cancer Biology center
Huazhong University of Science and Technology