NCT07047989

NWRD09 for HPV-16 Related Cervical HSIL

Safety, Tolerability and Immunogenicity Study of NWRD09 in HPV16 Related Cervical High-grade Squamous Intraepithelial Lesions (HSlL)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Newish Biotech (Wuxi) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open label, multi-center clinical study to evaluate the safety, tolerability and immunogenicity HPV16 targeted mRNA therapeutic vaccine (NWRD09) in HPV16 related cervical high-grade squamous intraepithelial lesions (HSlL).

Detailed description

This study is divided into three dose groups. Each patient will be administered NWRD09 by intramuscular injection at week 0,2,4 and12. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. The subjects shall continue to receive safety follow-up until 28 days after the third administration. Colposcopy and biopsy were performed at week 24. This study will select 1-2 dose levels for subject expansion based on the dose escalation phase, to further evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in HPV16 related cervical HSIL patients.

Conditions

• High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

Type	Name	Description
BIOLOGICAL	NWRD09 injection	NWRD09 administered by intramuscular injection

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: China