NCT06741150

NWRD09 for HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.

Safety and Efficacy Study of NWRD09 in HPV-16 Positive and 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 positive and 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 cohort A and cohort B. 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.

Conditions

• Intraepithelial Neoplasia
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	NWRD09 administered by intramuscular injection	Intramuscular injection administration was carried out according to the protocol design.

Timeline

• Start date: 2024-06-24
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: China