NWRD09 for Persistent Cervical HPV16 Infection

July 13, 2026 updated by: Newish Biotech (Wuxi) Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of NWRD09 in Patients With Persistent Cervical HPV16 Infection

This is a randomized, double-blind, placebo controlled study to determine the efficacy and safety of NWRD09 in adult women with persistent cervical HPV16 infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD09 in patients with persistent cervical HPV16 infection who may or may not have concomitant cervical LSIL. Eligible participants will be randomized in a 1:1 ratio to two groups: NWRD09 and placebo.

Participants will receive intramuscular injections of either NWRD09 or placebo at the corresponding dose at weeks 0, 2, 4, and 12 (a total of 4 doses).

Efficacy evaluations at Week 16 will include cervical cytology and HPV testing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jian Zhao, M.D.
  • Phone Number: +86-15601199333
  • Email: 854496@qq.com

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female, aged 45 to 65 years (inclusive).
  2. Documented positive result for HPV 16 from a cervical sample collected at screening, with a confirmed duration of positivity for at least 12 months before screening.
  3. Satisfactory colposcopy examination. For participants with concomitant cervical LSIL, the entire aceto-white staining area or the suspected cervical intraepithelial neoplasia (CIN) lesion, including the upper border of the transformation zone, must be fully visualized.
  4. Adequate organ function within 1 week before the first dose, defined as:

1) Hematology: Hemoglobin (Hb) ≥ 100 g/L; Platelet count (PLT) ≥ 75 × 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.

2) Hepatic: Total bilirubin (TB) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Plasma albumin ≥ 30 g/L.

3) Renal: Serum creatinine (Scr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 60 mL/min (using the Cockcroft-Gault formula) [for participants with serum creatinine > 1.5 × ULN].

(5) For premenopausal women of childbearing potential: a negative serum pregnancy test within 7 days 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 (at Week 12).

(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.

Exclusion Criteria:

  1. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer.
  2. Cervical cytology results indicating ASC-H (Atypical Squamous Cells - cannot exclude HSIL), HSIL (High-grade Squamous Intraepithelial Lesion), SCC (Squamous Cell Carcinoma), AGC (Atypical Glandular Cells), or AIS; *Exception: Participants with ASC-H or HSIL may be enrolled if histopathological evidence confirms no lesion or CIN1, upon investigator's assessment.*.
  3. Pregnant or lactating women, or individuals planning to conceive during the study period.
  4. Participation in another clinical trial within 30 days before screening, or currently within the observational follow-up period of another clinical trial.
  5. Continuous systemic corticosteroid therapy (at a dose equivalent to >10 mg/day of prednisone) for more than one week within 30 days before screening; Exceptions: Hormone replacement therapy, and local administration (e.g., intra-tracheal, ocular).
  6. Continuous use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, antilymphocyte globulin) for more than one week within 30 days before screening.
  7. Administration of any non-live vaccine within 4 weeks, or any live vaccine within 4 weeks, before the first dose.
  8. History of receiving any therapeutic HPV vaccination; Note: Vaccination with approved prophylactic HPV vaccines is acceptable.
  9. Use of blood or blood-derived products (including immunoglobulins) within 3 months before the first dose, or planned use during the study period.
  10. History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
  11. Current or anticipated use during the study period of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) or biologic disease-modifying agents (e.g., infliximab, adalimumab, etanercept).
  12. History of solid organ or bone marrow transplantation.
  13. History or current diagnosis of other malignancies.
  14. Presence of active infection requiring systemic therapy (including active tuberculosis, active syphilis, and bacterial, fungal, or viral infections requiring systemic treatment).
  15. Positive test results for any of the following: Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (anti-HCV), Treponema pallidum antibody (TP-Ab), or Human Immunodeficiency Virus antibody (anti-HIV).
  16. Known history of allergy to any component of the investigational product or similar drugs; or history of severe allergy to any food, drug, or other substances (e.g., urticaria, eczema, dyspnea, angioedema).
  17. Severe dysfunction of other organs or severe cardiopulmonary disease.
  18. Presence of tattoos, scars, or active lesions/rashes within a 2 cm radius of the intended injection site (deltoid muscle) that may interfere with safety assessment.
  19. Known psychiatric disorders or substance abuse disorders that may interfere with the subject's ability to comply with study requirements.
  20. Any condition, therapy, laboratory abnormality, history of other circumstances, or current evidence that, in the investigator's judgment, may increase the risk associated with study participation or investigational product administration, may interfere with the interpretation of study results, or render the participant unsuitable for enrollment in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NWRD09
Each participant will be administered NWRD09 by IM injection at weeks 0, 2, 4, and 12.
Biological: NWRD09/ Placebo administered by IM injection
NWRD09/ Placebo
Placebo Comparator: Placebo
Each participant will be administered placebo by IM injection at weeks 0, 2, 4, and 12.
Biological: NWRD09/ Placebo administered by IM injection
NWRD09/ Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with virologically-proven clearance of HPV 16 at week 16.
Time Frame: Week 16
The number of participants with virologically-proven clearance of HPV 16 at week 16.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of local and systemic adverse events (AEs).
Time Frame: up to 36 weeks
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, adverse events (AEs) and serious adverse events (SAEs) will be monitored.
up to 36 weeks
Proportion of participants with virologically-proven clearance of HPV 16 at week 28.
Time Frame: 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.
Time Frame: Weeks 16、28
The number of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
Weeks 16、28
Proportion of participants with baseline cervical LSIL showing histopathological regression to no lesions at 28 weeks after the first dose.
Time Frame: Week 28
The number of participants with cervical LSIL showing histopathological regression to no lesions at week 28.
Week 28
Levels of cellular immune responses.
Time Frame: Weeks 6, 16 , 28
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newish Biotech (Wuxi) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NWRD09-201

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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