Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL

NCT07175662 | Recruiting Phase 2

• 1 other identifier: NWRD08-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) 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 and/or HPV18.

Conditions

High-grade Squamous Intraepithelial Lesion (HSIL)

Keywords

cervical HSIL; NWRD08; HPV16; HPV18

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or no lesions at week 36

  The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or no lesions at the 36 week visit.

  Week 36

Secondary Outcomes (14)

• Incidence and severity of local and systemic adverse events (AEs).

  up to 40 weeks

• Incidence and severity of adverse events (AEs) at the injection site.

  up to 40 weeks

• Incidence and severity of all serious adverse events (SAEs).

  up to 40 weeks

• Pregnancy occurrences and outcomes during the study period

  up to 40 weeks

• Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.

  up to 40 weeks

Study Arms (4)

2mg NWRD08

EXPERIMENTAL

Each patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16.

Biological: NWRD08 administered by electroporation

4mg NWRD08

EXPERIMENTAL

Each patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16.

Biological: NWRD08 administered by electroporation

Placebo for the 2 mg NWRD08 arm

PLACEBO COMPARATOR

Each patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16.

Biological: Placebo administered by electroporation

Placebo for the 4 mg NWRD08 arm

PLACEBO COMPARATOR

Each patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16.

Biological: Placebo administered by electroporation

Interventions

NWRD08 administered by electroporation BIOLOGICAL

NWRD08 delivered via IM injection + electroporation using TERESA device

2mg NWRD08; 4mg NWRD08

Placebo administered by electroporation BIOLOGICAL

Placebo delivered via IM injection + electroporation using TERESA device

Placebo for the 2 mg NWRD08 arm; Placebo for the 4 mg NWRD08 arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Aged 18 to 60 years, female.
• \. Confirmed by the central laboratory, histopathology results demonstrated cervical HSIL with concurrent HPV16 and/or HPV18 positivity.
• \. Colposcopy results during screening must meet the following criteria:
• The colposcopy must be satisfactory, allowing clear visualization of the entire acetowhite area or the extent of suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper border of the lesion.
• If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
• The cervical lesion area must be less than 75% of the surface of the ectocervix.
• \. Fully understand the study and voluntarily sign the informed consent form, able to communicate well with the investigator and complete all treatments, examinations, and visits as required by the study protocol. The informed consent form must be signed before performing any study-specific procedures.
• \. At screening, the investigator judges the electrocardiogram (ECG) as normal or without clinically significant findings.
• \. Normal function of major organs within 1 week before the first dose: Blood routine: Hemoglobin (Hb) ≥100 g/L; platelet count (PLT) ≥75×10⁹/L; white blood cell count (WBC) ≥3.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L.
• Liver: 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.
• Kidney: Serum creatinine (Scr) ≤1.5 × ULN, or creatinine clearance rate ≥60 mL/min (calculated by Cockcroft-Gault formula) (if serum creatinine \>1.5 × ULN).
• \. Women of childbearing potential must be willing to consistently and correctly use a contraceptive method with a failure rate of less than 1% per year from the time of signing the informed consent form until the end of the study. Acceptable methods include:
• Hormonal contraceptives: Combined or progestin-only methods, including oral contraceptives, injections, implants, vaginal rings, or transdermal patches. Subjects with a history of hypercoagulable states (e.g., deep vein thrombosis, pulmonary embolism) must not use hormonal contraceptives.
• Abstinence from penile-vaginal intercourse.
• Intrauterine device (IUD) or intrauterine system (IUS).

You may not qualify if:

• Patients with any of the following were excluded from the study:
• Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
• Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Administration 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.
• Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
• Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before screening.
• Treatment for cervical HSIL within 4 weeks prior to the first dose.
• Presence of metal implants or implantable medical devices within the electroporation area.
• Participation in another clinical trial within 30 days prior to screening or being in the follow-up period of another clinical trial.
• Continuous (for more than 1 week) systemic treatment with corticosteroids (at a dose equivalent to \>10 mg/day prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 30 days prior to screening, with the following exceptions.
• Inhaled, ophthalmic, or topical use of corticosteroids at doses ≤10 mg/day prednisone or equivalent is permitted.
• Physiological corticosteroid replacement therapy at doses ≤10 mg/day prednisone or equivalent is permitted.
• History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.) or current active autoimmune diseases requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs).
• Current or anticipated use of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease-modifying drugs (e.g., infliximab, adalimumab, etanercept) during the study.
• Continuous (for more than 1 week) use of immunosuppressants such as cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and antilymphocyte globulin, as well as other inhibitors affecting immune function (e.g., IL-6 inhibitors, TNF inhibitors, IL-17/23 inhibitors, JAK inhibitors) within 30 days prior to screening.

Sponsors & Collaborators

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

Study Sites (5)

Cancer Institute and Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, 100026, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Xiang, M.D.

CONTACT

+86-010-69155635; xiangy@pumch.cn

Fang Jiang

CONTACT

+86-010-69155635; 13671170943@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 16, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-09

Locations

CN (5)