drugset / Trial / NCT07170254
A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL
Recruiting
12 enrolled
Shanghai BDgene Co., Ltd.
Obstetrics & Gynecology Hospital of Fudan University · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is intented to evaluate the safety, and tolerability and preliminary efficacy of Instantaneous CRISPR/Cas9 Gene Editing Therapy (BD114 virus-like particle, also BD114) for the treatment of high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 infection.
Timeline
- Start
- 2025-09
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BD114VLP | CRISPR / gene editing | 0.1 ml | Other |
| Subject | BD114VLP | CRISPR / gene editing | 0.2 ml | Other |
| Subject | BD114VLP | CRISPR / gene editing | 0.3 ml | Other |
| Subject | BD114VLP | CRISPR / gene editing | 0.4 ml | Other |
| Subject | BD114VLP | CRISPR / gene editing | 0.6 ml | Other |