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Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD08 in Patients With HPV16/18-Positive Cervical High-Grade Squamous Intraepithelial Lesion (HSIL)

NCT07175662•Newish Biotech (Wuxi) Co., Ltd.

View on ClinicalTrials.gov

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.

Detailed Description

This is a Phase II, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD08 in patients with HPV16 and/or HPV18 positive cervical high-grade squamous intraepithelial lesion (HSIL). Eligible subjects will be randomized in a 2:2:1:1 ratio to four arms: 2 mg NWRD08, 4 mg NWRD08, and their respective matching placebo arms. Participants will receive intramuscular injections of either NWRD08 or matching placebo at the corresponding dose at Week0, 4, 8, and 16 (a total of 4 doses). Efficacy evaluations at Week 36 will include colposcopy, histopathological biopsy, cervical cytology, and HPV testing.

Eligibility

Age

18 - 60 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1\. Aged 18 to 60 years, female.
•2\. Confirmed by the central laboratory, histopathology results demonstrated cervical HSIL with concurrent HPV16 and/or HPV18 positivity.
•3\. Colposcopy results during screening must meet the following criteria:
•1. 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.
•2. If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
•3. The cervical lesion area must be less than 75% of the surface of the ectocervix.
•4\. 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.
•5\. At screening, the investigator judges the electrocardiogram (ECG) as normal or without clinically significant findings.
•6\. 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.
+8 more criteria

Exclusion Criteria

•Patients with any of the following were excluded from the study:
•1. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
•2. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
•3. 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.
•4. Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
•5. Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before screening.
•6. Treatment for cervical HSIL within 4 weeks prior to the first dose.
•7. Presence of metal implants or implantable medical devices within the electroporation area.
•8. Participation in another clinical trial within 30 days prior to screening or being in the follow-up period of another clinical trial.
•9. 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.
+18 more criteria

Locations (5)

Cancer Institute and Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Key Dates

Start Date

November 11, 2025

Primary Completion Date

May 30, 2027

Completion Date

August 30, 2027

Last Updated

February 17, 2026

Enrollment

150

ESTIMATED participants

Conditions

High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

NWRD08 administered by electroporation

BIOLOGICAL

Placebo administered by electroporation

BIOLOGICAL

Contacts

Yang Xiang, M.D.

CONTACT

+86-010-69155635 xiangy@pumch.cn

Fang Jiang

CONTACT

+86-010-69155635 13671170943@163.com