An Exploratory Clinical Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region: Safety and Preliminary Efficacy Observation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence and severity of local and systemic adverse events (AEs).
研究概览
简要总结
This is an open-label, single-center, investigator-initiated exploratory trial evaluating NWRD09 in 10 participants with persistent HPV16 infection in the anal region.
详细描述
This is an open-label, single-center, investigator-initiated clinical trial (IIT) designed to evaluate the efficacy, safety, and immunogenicity of NWRD09 in patients with persistent HPV16 infection localized to the anal region. A total of 10 participants will be enrolled and allocated to two parallel treatment groups. Participants are assigned to two parallel treatment groups, with one sentinel participant per group. Sentinel safety observation over 7 days post-first dose precedes enrollment of subsequent participants. Objectives include assessment of safety/tolerability, HPV16 DNA clearance, cytological regression, histopathological improvement (for baseline AIN1), and cellular immune responses through Week 28.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male, aged 18 to 60 years (inclusive).
- •HPV DNA genotyping of anal specimens demonstrates positivity for HPV16, with documented persistence for at least 12 months (≥12 months).
- •Histopathological findings show low-grade lesion, inflammation, or no abnormality.
- •Adequate organ function within 4 week before the first dose.
- •For premenopausal women of childbearing potential: a negative serum pregnancy test within 4 weeks before the first dose. Eligible participants of childbearing potential and their partners must agree to use highly effective contraception throughout the trial and for 6 months after the last study dose.
- •Ability to understand the study and voluntarily provide written informed consent (ICF), willingness and ability to communicate effectively with the investigator, and to comply with all protocol-required treatment, examinations, and visits.
排除标准
- •Any histopathologically confirmed adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer.
- •Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
- •Participation in another clinical trial within 30 days prior to screening, or currently being in the follow-up period of another clinical trial.
- •Continuous use (for >1 week) of systemic corticosteroids at a dose equivalent to >10 mg/day of prednisone within 30 days prior to screening, with the exception of hormone replacement therapy and topical administration (e.g., intratracheal, ophthalmic).
- •Continuous use (for >1 week) of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, antilymphocyte globulin) within 30 days prior to screening.
- •Receipt of any inactivated or live vaccine within 4 weeks prior to the first dose of study drug.
- •Receipt of any AIN-related drug or physical therapy within 4 weeks prior to the first dose.
- •History of any therapeutic HPV vaccination (prior receipt of licensed prophylactic HPV vaccines is acceptable).
- •Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose, or planned use during the study period.
- •History of immunodeficiency or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.).
结局指标
主要结局
Incidence and severity of local and systemic adverse events (AEs).
时间窗: Up to 28 weeks
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V6.0, adverse events (AEs) and serious adverse events (SAEs) will be monitored.
次要结局
- Proportion of participants with virologically-proven clearance of HPV 16 at week 16.(Week 16)
- Proportion of participants with virologically-proven clearance of HPV 16 at week 28.(Week 28)
- Proportion of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.(Weeks 16、28)
- Proportion of participants with baseline AIN1 showing histopathological regression to no lesions at 28 weeks after the first dose.(Week 28)
- Levels of cellular immune responses.(Weeks 6, 16 , 28)