NCT07092007

NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer

Safety and Efficacy Study of NWRD09 in HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (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, two cohorts, multi-center clinical study to evaluate the safety and efficacy of HPV-16 targeted mRNA vaccine (NWRD09) in HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).

Detailed description

This study is divided into three dose groups in two cohorts. Each patient will be administered NWRD09 by intramuscular injection. 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. For cohort A, the subjects shall continue to receive safety follow-up until 14 days after the last administration. Colposcopy and biopsy were performed at week 24. For cohort B, the subjects shall continue to receive safety follow-up until 14 days after the last administration. Imaging evaluation was performed every 6 weeks.

Conditions

• Intraepithelial Neoplasia
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	NWRD09 administered by intramuscular injection	NWRD09 administered by intramuscular injection according to the study protocol.

Timeline

• Start date: 2024-06-05
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: China