Evaluation of NWRD09 for HPV-16 Related Cervical HSIL (NCT07712692) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of NWRD09 for HPV-16 Related Cervical HSIL
China156 participantsStarted 2026-08-01
Plain-language summary
This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD09 administered by intramuscular (IM) injection in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
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
. Age between 18 and 65 years (inclusive), female;
. Confirmed by the central laboratory: histopathologically diagnosed cervical high-grade squamous intraepithelial lesion (HSIL) and HPV genotyping positive for HPV16;
. Colposcopy results at each study center during the screening period must meet the following criteria:
. Liver: total bilirubin (TB) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; plasma albumin ≥ 30 g/L;
. Kidney: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 40 mL/min (calculated by Cockcroft-Gault formula); (5) For premenopausal women with childbearing potential, serum pregnancy test within 14 days before the first dose must be negative. Eligible participants of childbearing potential and their spouse/partner must agree to use effective contraceptive measures during the study period or until 64 weeks after the first dose; (6) Fully understand the study and voluntarily sign the informed consent form (ICF), be able to communicate well with the investigator, and be able to complete all treatments, examinations, and visits as required by the study protocol.
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
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), vulvar, vaginal, or anal high-grade intraepithelial lesions, or invasive cancer;
. Women who are pregnant or breastfeeding, or who plan 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 more than 1 week) of systemic glucocorticoid therapy (at a dose equivalent to \>10 mg/day prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 30 days prior to screening, except for the following:
. Inhaled, ophthalmic, or topical glucocorticoid therapy at a dose ≤10 mg/day prednisone or equivalent is permitted;
. Physiological glucocorticoid replacement therapy at a dose ≤10 mg/day prednisone or equivalent;
. Continuous use (for more than 1 week) of immunosuppressants such as cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, anti-lymphocyte globulin, etc., within 30 days prior to screening;
. Receipt of any live vaccine within 4 weeks prior to the first dose, and/or any non-live vaccine within 2 weeks prior to the first dose;