Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

July 14, 2026 updated by: Newish Biotech (Wuxi) Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD09 in Patients With HPV16-Positive Cervical High-Grade Squamous Intraepithelial Lesion (HSIL)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD09 in patients with HPV16 positive cervical high-grade squamous intraepithelial lesion (HSIL). Eligible participants are randomized to receive either NWRD09 or the corresponding placebo.

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

Efficacy evaluations at Week 24 will include histopathological biopsy and HPV testing.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 2

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 Backup

Study Locations

  • China
      • Dalian, China
        • Dalian Maternal and Child Health Hospital
        • Contact:
          • Lu Han
        • Principal Investigator:
          • Lu Han, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Yi Yang, M.D.
      • Beijing, Beijing Municipality, China
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Yue He, M.D.
      • Beijing, Beijing Municipality, China
        • Peking University First Hospital
        • Contact:
          • Jian Zhao, M.D.
          • Phone Number: 86-010-69119025
          • Email: 854496@qq.com
        • Principal Investigator:
          • Jian Zhao, M.D.
      • Beijing, Beijing Municipality, China
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Bin Li, M.D.
        • Contact:
        • Sub-Investigator:
          • Nanan Lv, M.D.
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Chongqing University Cancer Hospital
        • Principal Investigator:
          • Dongling Zou, M.D.
        • Contact:
      • Chongqing, Chongqing Municipality, China
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
        • Contact:
          • Yanzhou Wang, M.D.
        • Principal Investigator:
          • Yanzhou Wang, M.D.
    • Gansu
      • Lanzhou, Gansu, China
        • Gansu Provincial Maternity and Child-care Hospital / Gansu Provincial central Hospital
        • Contact:
          • Ru lin, M.M.
        • Principal Investigator:
          • Ru Lin, M.M.
    • Hebei
      • Baoding, Hebei, China
        • Affiliated Hospital of Hebei University
        • Contact:
        • Principal Investigator:
          • Yijuan Liang, M.M.
    • Henan
      • Zhengzhou, Henan, China
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:
          • Hui Chen, M.D.
          • Phone Number: 86-0371-63930334
        • Principal Investigator:
          • Hui Chen, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Maternity and Child Health Care Hospital
        • Contact:
        • Contact:
          • Boqun Xu, M.D.
          • Phone Number: 86-025-52226919
        • Principal Investigator:
          • Boqun Xu, M.M.
    • Jilin
      • Changchun, Jilin, China
        • The Second Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Tianmin Xu, M.D.
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Youzhong Zhang, M.D.
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Maternal and Child Health Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoli Li, M.M.
      • Xi’an, Shanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Ruifang An, M.D.
          • Phone Number: 86-029-85323473
        • Principal Investigator:
          • Ruifang An, M.D.

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants had to meet all of the following inclusion criteria:

  1. Age between 18 and 65 years (inclusive), female;
  2. Confirmed by the central laboratory: histopathologically diagnosed cervical high-grade squamous intraepithelial lesion (HSIL) and HPV genotyping positive for HPV16;
  3. Colposcopy results at each study center during the screening period must meet the following criteria:

1) The colposcopy examination is adequate, allowing clear visualization of the entire area of acetowhite epithelium or suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper margin of the lesion; 2) If the upper margin of the lesion is not clearly visible, the endocervical curettage (ECC) result must be negative; 3) The area of cervical lesion is less than 75% of the cervical area visible by colposcopy; (4) Within 14 days (inclusive) before the first dose, major organ function meets the following criteria:

  1. Hematology: hemoglobin (Hb) ≥ 100 g/L; platelet count (PLT) ≥ 75 × 10⁹/L; absoluteneutrophil count ≥ 1.8 × 10⁹/L;
  2. 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;
  3. 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.

Exclusion Criteria:

Participants with any of the following were excluded from the study:

  1. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), vulvar, vaginal, or anal high-grade intraepithelial lesions, or invasive cancer;
  2. Women who are pregnant or breastfeeding, or who plan 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 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:

    1. Inhaled, ophthalmic, or topical glucocorticoid therapy at a dose ≤10 mg/day prednisone or equivalent is permitted;
    2. Physiological glucocorticoid replacement therapy at a dose ≤10 mg/day prednisone or equivalent;
  5. 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;
  6. 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;
  7. Any history of therapeutic HPV vaccination (approved prophylactic HPV vaccination is acceptable);
  8. Receipt of any drug or physical therapy for HSIL within 4 weeks prior to screening;
  9. Use of blood or blood-related products (including immunoglobulin) 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.), or currently active autoimmune disease requiring systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants);
  11. Current or anticipated continuous use (for more than 1 week) of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease-modifying antirheumatic drugs (e.g., infliximab, adalimumab, etanercept) during the study period;
  12. History of solid organ or bone marrow transplantation;
  13. Previous or current other malignancy;
  14. Uncontrolled serious infection (> Grade 2 NCI-CTCAE, version 6.0);
  15. Positive test for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; positive for hepatitis B surface antigen (HBsAg) unless HBV-DNA ≤ 2500 copies/mL or ≤ 500 IU/mL or within the normal range of the study site;
  16. Known allergy to any component of the investigational drug or similar drugs; history of severe allergic reactions to food, drugs, or other substances (e.g., urticaria, eczema, dyspnea, angioedema, etc.);
  17. Tattoos, scars, or active lesions/rash within 2 cm of the intended injection site (deltoid of the upper arm) that may affect safety observation;
  18. Severe dysfunction of other organs or cardiopulmonary disease;
  19. Definite history of neurological or psychiatric disorders, including epilepsy or dementia;
  20. History of drug abuse or alcohol use disorder;
  21. History or current evidence of any condition, treatment, laboratory abnormality, or other circumstances that may increase the risk of study participation or investigational product administration, or may interfere with interpretation of study results, and in the judgment of the investigator, make 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
Intervention / Treatment
Experimental: 10 ug NWRD09
Biological: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Experimental: 20 ug NWRD09
Biological: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Placebo Comparator: Placebo for the 10 ug NWRD09 arm
Biological: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
Placebo Comparator: Placebo for the 20 ug NWRD09 arm
Biological: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
Time Frame: Week24
The number of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to CIN 1 or no lesions at the 24 week visit.
Week24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of local and systemic adverse events (AEs).
Time Frame: Up to week 64
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 week 64
Incidence and severity of all serious adverse events (SAEs).
Time Frame: Up to week 64
Incidence and severity of all serious adverse events (SAEs) during the study period (e.g., suspected unexpected serious adverse reactions, unexpected adverse device effects).
Up to week 64
Pregnancy occurrences and outcomes during the study period.
Time Frame: Up to week 64
Pregnancy occurrences and outcomes during the study period
Up to week 64
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Time Frame: Up to week 64
Incidence of AEs leading to discontinuation of study treatment that are related to the investigational product.
Up to week 64
Proportion of Participants with Histopathological Regression of Cervical Lesions to no lesions.
Time Frame: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to no lesions at the 24 week visit.
Week 24
Proportion of Participants with Histopathological regression of Cervical Lesions to LSIL/CIN1.
Time Frame: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to LSIL/CIN1 at the 24 week visit.
Week 24
Proportion of Participants with Virologically-proven Clearance of HPV 16.
Time Frame: Week 24
Proportion of participants with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL(LSIL /CIN1 or lesion) and with Virologically-proven Clearance of HPV 16.
Time Frame: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to LSIL/CIN1 or no lesion and with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression of Cervical Lesions to no Lesion and with Virologically-proven Clearance of HPV 16.
Time Frame: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress completely to no lesion and with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression to non-HSIL (LSIL/CIN1 or no lesion) in Participants with Baseline HPV16-only Infection.
Time Frame: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and HPV16-only infection whose cervical lesions regress histopathologically to non-HSIL (LSIL/CIN1 or no lesion) at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression to no Lesion in Participants with Baseline HPV16-only Infection.
Time Frame: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and HPV16-only infection whose cervical lesions regress histopathologically to no lesion at week 24 visit.
Week 24
Proportion of Participants with Virologically-proven Clearance of Both HPV16 and non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
Time Frame: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and co-infection with non-HPV16 who achieve clearance of both HPV16 and non-HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Virologically-proven Clearance of non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
Time Frame: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and co-infection with non-HPV16 who achieve clearance of non-HPV16 on cervical genotyping at week 24 visit.
Week 24
Levels of cellular immune responses.
Time Frame: Weeks 4, 8, 16, 24 and 48
Levels of cellular immune responses measured by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay in peripheral blood mononuclear cells (PBMCs) of subjects at baseline and at Weeks 4, 8, 16,24 and 48.
Weeks 4, 8, 16, 24 and 48
Levels of serum anti-HPV16 antibody titers.
Time Frame: Weeks 4, 8, 16, 24 and 48
Levels of serum anti-HPV16 antibody titers measured in peripheral blood samples collected at baseline and at Weeks 4, 8, 16, 24 and 48.
Weeks 4, 8, 16, 24 and 48

Collaborators and Investigators

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

Sponsor

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 14, 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 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NWRD09-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on High-grade Squamous Intraepithelial Lesion (HSIL)

Clinical Trials on NWRD09 Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe