Persistent HPV16 InfectionPhase 1NCT07710664
A Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region
A Phase 1 study testing NWRD09 in people with Persistent HPV16 Infection, run by Newish Biotech (Wuxi) Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Persistent HPV16 Infection
- What is being tested?
- NWRD09
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Dr. Chen Zeyang, MD, +86-13051555186, chenzeyang_pku@163.com
About this study
Official title: An Exploratory Clinical Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region: Safety and Preliminary Efficacy Observation
This is an open-label, single-center, investigator-initiated exploratory trial evaluating NWRD09 in 10 participants with persistent HPV16 infection in the anal region.
Read the detailed description
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.
- Conditions
- Persistent HPV16 Infection
- Being tested
- NWRD09
- Keywords
- persistent HPV16 infection, therapeutic mRNA vaccine, NWRD09
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWRD09Drug
Each participant will be administered NWRD09 by IM injection
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment group | Experimental | Not described Receives: Drug: NWRD09 |
| Sparse treatment group | Experimental | Not described Receives: Drug: NWRD09 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of local and systemic adverse events (AEs).
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.
Measured: Up to 28 weeks
Secondary outcomes (5)
Proportion of participants with virologically-proven clearance of HPV 16 at week 16.
The number of participants with virologically-proven clearance of HPV 16 at week 16.
Measured: Week 16
Proportion of participants with virologically-proven clearance of HPV 16 at week 28.
The number of participants with virologically-proven clearance of HPV 16 at week 28.
Measured: Week 28
Proportion of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
The number of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
Measured: Weeks 16、28
Proportion of participants with baseline AIN1 showing histopathological regression to no lesions at 28 weeks after the first dose.
The number of participants with AIN1 showing histopathological regression to no lesions at week 28.
Measured: Week 28
Levels of cellular immune responses.
Levels of cellular immune responses measured by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay in peripheral blood mononuclear cells (PBMCs) of participants at baseline and at weeks 6, 16, 28.
Measured: Weeks 6, 16 , 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent HPV16 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pengyuan Wang, MD, Principal investigator, Peking University First HospitalZeyang Chen, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710664
- Sponsor's protocol ID
- NWRD09-104
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region: Safety and Preliminary Efficacy Observation
- ClinicalTrials.gov ID
- NCT07710664
- Acronym / sponsor ID
- NWRD09-104
- Conditions
- Persistent HPV16 Infection
- Keywords
- persistent HPV16 infection, therapeutic mRNA vaccine, NWRD09
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-center, investigator-initiated exploratory trial evaluating NWRD09 in 10 participants with persistent HPV16 infection in the anal region.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment group | Experimental | Drug: NWRD09 |
| Sparse treatment group | Experimental | Drug: NWRD09 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NWRD09Each participant will be administered NWRD09 by IM injection | Drug | Intensive treatment group, Sparse treatment group |
Primary outcome
Incidence and severity of local and systemic adverse events (AEs).
Time frame: 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.
5 secondary outcomes
Proportion of participants with virologically-proven clearance of HPV 16 at week 16.
Time frame: Week 16
Proportion of participants with virologically-proven clearance of HPV 16 at week 28.
Time frame: Week 28
Proportion of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
Time frame: Weeks 16、28
Proportion of participants with baseline AIN1 showing histopathological regression to no lesions at 28 weeks after the first dose.
Time frame: Week 28
Levels of cellular immune responses.
Time frame: Weeks 6, 16 , 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengyuan Wang, MD principal investigator
Peking University First Hospital
Zeyang Chen, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NWRD09 in people with Persistent HPV16 Infection, run by Newish Biotech (Wuxi) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Chen Zeyang, MD (+86-13051555186, chenzeyang_pku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of local and systemic adverse events (AEs). (time frame: Up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.