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.


Approximately 10.900 people are diagnosed with cervical cancer in the US per year.
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 Neoplasia

Principal Investigator: Zheng Hu, M.D.  First Affiliated Hospital, Sun Yat-Sen University


China, Guangdong


Study start:
Jan. 15, 2018
60 participants
Gene editing method:
HPV16 and HPV18 E6/E7
No information
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown


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: May. 18, 2020