A Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent HPV16 Infection
• Intervention / Treatment: Drug: NWRD09

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr. Chen Zeyang, MD; Phone Number: +86-13051555186; Email: chenzeyang_pku@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University First Hospital
    • Contact: Dr. Chen Zeyang, MD; Phone Number: +86-13051555186; Email: chenzeyang_pku@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female and male, aged 18 to 60 years (inclusive).
2. HPV DNA genotyping of anal specimens demonstrates positivity for HPV16, with documented persistence for at least 12 months (≥12 months).
3. Histopathological findings show low-grade lesion, inflammation, or no abnormality.
4. Adequate organ function within 4 week before the first dose.
5. 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.
6. 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.

Key Exclusion Criteria:

1. Any histopathologically confirmed adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer.
2. Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
3. Participation in another clinical trial within 30 days prior to screening, or currently being in the follow-up period of another clinical trial.
4. 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).
5. Continuous use (for >1 week) of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, antilymphocyte globulin) within 30 days prior to screening.
6. Receipt of any inactivated or live vaccine within 4 weeks prior to the first dose of study drug.
7. Receipt of any AIN-related drug or physical therapy within 4 weeks prior to the first dose.
8. History of any therapeutic HPV vaccination (prior receipt of licensed prophylactic HPV vaccines is acceptable).
9. Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose, or planned use during the study period.
10. History of immunodeficiency or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive treatment group	Drug: NWRD09; Each participant will be administered NWRD09 by IM injection
Experimental: Sparse treatment group	Drug: NWRD09; Each participant will be administered NWRD09 by IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Weeks 16、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.	Weeks 6, 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.	Week 28

Collaborators and Investigators

• Sponsor: Newish Biotech (Wuxi) Co., Ltd.
• Investigators: Principal Investigator: Pengyuan Wang, MD, Peking University First Hospital; Principal Investigator: Zeyang Chen, MD, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NWRD09; persistent HPV16 infection; therapeutic mRNA vaccine
• Other Study ID Numbers: NWRD09-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No