RecruitingPhase 2NCT07175662

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)


Sponsor

Newish Biotech (Wuxi) Co., Ltd.

Enrollment

150 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called NWRD08 administered by electroporation and a biological treatment called Placebo administered by electroporation for people with high-grade squamous intraepithelial lesion (hsil). The study is currently recruiting participants at 5 locations. People eligible for this study include women aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNWRD08 administered by electroporation

NWRD08 delivered via IM injection + electroporation using TERESA device

BIOLOGICALPlacebo administered by electroporation

Placebo delivered via IM injection + electroporation using TERESA device


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

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NCT07175662


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