Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection

A Phase I/IIa, Randomized, Double Blind, Placebo Controlled, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of NWRD09 Injection in Female Participants With Persistent HPV16 Infection

This is a two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09.

Study Overview

• Status: Not yet recruiting
• Conditions: Persistent HPV16 Infection
• Intervention / Treatment: Biological: NWRD09; Biological: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: June Y. Hou, MD; Phone Number: 212-305-3410; Email: jh3558@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
      • Contact: June Y. Hou, MD; Phone Number: 212-305-3410; Email: irboffice@columbia.edu
      • Principal Investigator: June Y. Hou, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants who have fully understood the study, able and willing to comply with all study procedures, and voluntarily sign written ICF;
• Female participants aged 18-60 years (inclusive) at the time of signing the ICF;
• Persistent HPV16 infection, defined as virologically confirmed HPV16 positivity persisting for ≥ 6 months before screening (e.g., participants must provide investigator-approved evidence of HPV16 infection ≥ 6 months prior to screening and be HPV16 positive at the time of screening);
• Participants must have a confirmed cytological results of atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H) or high-grade squamous intraepithelial lesion (HSIL) at the time of screening (histopathological confirmed cervical/vaginal/vulvar LSIL are acceptable but not required);
• Satisfactory colposcopy at screening;
• Normal major organ functions at screening;
• Women of child-bearing potential must have a negative serum pregnancy test result at screening. All WOCBP participants agree to voluntarily use effective contraception, from signing the ICF to the end of the study. In addition, female participants must agree not to donate eggs during this period.

Exclusion Criteria:

• Histopathological confirmed high-grade cervical, vulvar, vaginal or anal intraepithelial lesions (including endocervical adenocarcinoma-in-situ [AIS]) or invasive cancer, OR cervical cytology results showing squamous cell carcinoma (SCC), atypical glandular cells (AGC), or AIS at screening;
• Negative for HPV16 as confirmed by real-time quantitative polymerase chain reaction (RT-qPCR) at screening;
• Comorbid infectious diseases, such as acute pelvic inflammatory disease, urinary tract infection, or other active infections requiring systemic treatment prior to the first injection;
• Participants with unresolved vaginal/cervical conditions prior to the first injection that could affect clinical response (e.g., common sexually transmitted infections such as gonorrhoea, genital herpes, etc.);
• Positive serological test results at screening for human immunodeficiency virus (HIV), treponema pallidum antibody, or hepatitis B virus surface antigen (HBsAg) positive; or hepatitis C virus antibody (HCV-Ab) positive and hepatitis C virus (HCV) ribonucleic acid (RNA) quantitative > the lower limit of the positive detection value of the study site;
• Significant abnormalities at the screening ECG, including QTc interval > 470 msec (average of triplicate measurements corrected for heart rate using Fridericia's formula), or history/presence of clinical symptoms of cardiac diseases that is not well controlled, such as New York Heart Association (NYHA) Class 2 or higher heart failure, unstable angina, myocardial infarction within the past 6 months, and clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
• Systemic corticosteroid use (e.g., > 10 mg/day prednisone for > 1 week) within 30 days before screening, excluding hormone replacement therapy and local/topical use (e.g., ocular, intratracheal);
• Immunosuppressant use (> 1 week) within 30 days or 5 drug half-lives (whichever is longer) before screening (including but not limited to cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, or antilymphocyte globulin);
• Current or planned use of disease-modifying antirheumatic drugs (DMARDs, e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) or biologic DMARDs (e.g., infliximab, adalimumab, etanercept) during the study;
• Received any vaccine (other than HPV prophylactic vaccines) within 8 weeks before screening or plan to receive any vaccine during the study;
• History of therapeutic HPV vaccination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Participants will receive 4 injections of Placebo via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1)
Experimental: NWRD09; Predefined dose groups of NWRD09	Biological: NWRD09; Participants will receive 4 injections of NWRD09 via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of local and systemic adverse events (AEs).	Adverse events (AEs) and serious adverse events (SAEs) will be monitored based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.	Up to Week 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with clearance of HPV16	Weeks 16 and 28
Proportion of participants with cervical cytology normal/ASC-US/LSIL	Week 16 and 28
For participants with histopathological LSIL at baseline, proportion of participants with histopathological regression to NSIL	Week 28
T cell responses to the separate or combined protein peptide pools of HPV16 E1, E2, E6 and E7 proteins	Weeks 6, 16 and 28
Serum HPV16 E6/E7-specific IgG antibodies will be determined by ELISA	Weeks 6, 16 and 28

Collaborators and Investigators

• Sponsor: Newish Biotech (Wuxi) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: persistent HPV16 infection; therapeutic mRNA vaccine
• Other Study ID Numbers: NWRD09-103

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: Yes
• Studies a U.S. FDA-regulated device product: No