NCT07175662

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Newish Biotech (Wuxi) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

Type	Name	Description
BIOLOGICAL	NWRD08 administered by electroporation	NWRD08 delivered via IM injection + electroporation using TERESA device
BIOLOGICAL	Placebo administered by electroporation	Placebo delivered via IM injection + electroporation using TERESA device

Timeline

• Start date: 2025-11-11
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2025-09-16
• Last updated: 2026-02-17

Locations

5 sites across 1 country: China