A Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region (NCT07710664) | Clinical Trial Compass
RecruitingPhase 1
A Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region
China10 participantsStarted 2026-07-20
Plain-language summary
This is an open-label, single-center, investigator-initiated exploratory trial evaluating NWRD09 in 10 participants with persistent HPV16 infection in the anal region.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of local and systemic adverse events (AEs).
. 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).