Clinical Trial

Disease: Human papillomavirus (HPV)-Related Cervical Cancer, (NCT03057912)

Disease info:

Human Papillomavirus-HPV persistent infection is the major causal factor of cervical intraepithelial neoplasia (CIN) and cervical cancer.

Genital human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. More than 40 HPV types can infect the genital areas of men and women, including the skin of the penis, vulva (area outside the vagina), and anus, and the linings of the vagina, cervix, and rectum. These types can also infect the lining of the mouth and throat.

HPV types are often referred to as “low-risk” (wart-causing) or “high-risk” (cancer-causing), based on whether they put a person at risk for cancer.  When the body’s immune system can’t get rid of a high-risk HPV infection, it can linger over time and turn normal cells into abnormal cells and then cancer.

Two HPV types (16 and 18) cause 70% of cervical cancers and pre-cancerous cervical lesions.

 

 

Frequency:
The American Cancer Society estimates approximately 13,960 new cases of cervical cancer will be diagnosed in the United States in 2023.
Official title:
A Safety and Efficacy Study of Transcription Activator-like Effector Nucleases and Clustered Regularly Interspaced Short Palindromic Repeat/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ
Who:

Contact

Name: Zheng Hu, M.D.

Phone: 0086+18627803527

Email: 18627803527@163.com

 

Sponsor:

First Affiliated Hospital, Sun Yat-Sen University

Partners:

Jingchu University of Technology

Locations:

China, Guangdong

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China, 510080

Study start:
Jan. 15, 2018
Enrollment:
60 participants
Gene editing method:
CRISPR-Cas9 and TALEN
Type of edit:
Gene knock-out
Gene:
HPV16 and HPV18 oncogenes E6 and E7
Delivery method:
p-DNA - In-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/study/NCT03057912
Other links:

LinkWHO Human papillomavirus (HPV) and cervical cancerLinkHuman papillomavirus (HPV) frequency informationLinkHuman papillomavirus (HPV) related cervical cancer informationLinkDisruption of HPV16-E7 by CRISPR/Cas System Induces Apoptosis and Growth Inhibition in HPV16 Positive Human Cervical Cancer CellsLinkTALEN-mediated targeting of HPV oncogenes ameliorates HPV-related cervical malignancy

Note:
Using designated TALEN and CRISPR-Cas9 as genome editing tool could produce disruption of HPV16 and HPV18 E6/E7 DNA, significantly decreasing the expression of E6/E7, inducing cell apoptosis and inhibiting cell lines growth. Oncogenes E6 and E7 are expressed in the early stage of HPV infection, and their functions are to disrupt normal cell cycle and to maintain a transformed malignant phenotype.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown

Description

This is an open-label and triple cohort study of the safety and efficacy of TALEN and CRISPR-Cas9 to possibly treat HPV Persistency and human cervical intraepithelial neoplasia Ⅰ without invasion.

HPV persistent infection is the major causal factor of cervical intraepithelial neoplasia (CIN) and cervical cancer.
The important roles of E6 and E7 playing in HPV-driven carcinogenesis make them attractive targets for therapeutic interventions. Previous evidences showed that using designated TALEN and CRISPR-Cas9 as genome editing tool could produce disruption of HPV16 and HPV18 E6/E7 DNA, significantly decreasing the expression of E6/E7, inducing cell apoptosis and inhibiting cell lines growth. TALEN or CRISPR plasmid administered in gel twice one week for 4 weeks.

Last updated: Apr. 20, 2024
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