NCT06276101

NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL

Phase I Safety and Tolerability Study of NWRD08 in HPV-16 and/or HPV-18 Related Cervical High-grade Squamous Intraepithelial Lesion (HSIL) Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Newish Technology (Beijing) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.

Detailed description

This study is divided into three dose groups:1mg, 4mg, and 8mg. Each patient will be administered NWRD08 by electroporation in entire study period. The Maximum Tolerated Dose of NWRD08 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. After the completion of treatment, the subjects shall continue to receive safety follow-up until 28 days after the last administration. Colposcopy and biopsy were performed at week 12, if HSIL was identified, loop electro-surgical excisional procedure (LEEP) or cold Knife conization (CKC) will be performed when necessary. The subjects were then followed up at week 36 and all adverse events shall revert to level I or all adverse events shall be clinically stable (whichever is later achieved).

Conditions

• High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

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

Timeline

• Start date: 2024-01-25
• Primary completion: 2024-12-30
• Completion: 2025-07-30
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: China