NCT03226470

Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions

Safety Study of Transcription Activator-like Effector Nucleases T512 in HPV16-infected Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).

Detailed description

Persistent infection with high-risk human papillomavirus (HPVs),especially types 16 and 18,may lead to cervical intraepithelial neoplasia(CIN).HPVs expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies showed that using designated TALENs (T27 and T512) targeted HPV16 E6 and E7 produced disruption of HPV16 E6 and E7 DNA, decreased the expression of E6 and E7 proteins, and induced cell apoptosis. This study will evaluate the safety and efficacy of and T512 in treating HPV Persistency and HPV16-positive CIN.

Conditions

• Human Papillomavirus-Related Malignant Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	T512	T512 suppository contain 500 µg of T512 and suppocire.

Timeline

• Start date: 2017-03-10
• Primary completion: 2022-02-10
• Completion: 2022-06-10
• First posted: 2017-07-21
• Last updated: 2022-01-14

Locations

1 site across 1 country: China