Clinical Trial

Disease: Human papillomavirus (HPV) related Cervical Cancer, (NCT03226470)

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

 

Contact

Name: Ding Ma, M.D.

Phone: 86-27-83662681

Email: dma@tjh.tjmu.edu.cn

Partners:
Locations:

China, Hubei

Tongji Hospital, Wuhan, Hubei, China, 430030

Study start:
Mar. 10, 2017
Enrollment:
40 participants
Gene editing method:
TALENs
Type of edit:
Gene knock-out
Gene:
Human Papillomavirus type 16 (HPV16) E6 and E7
Delivery method:
Non-viral - In-vivo
Safety updates:

No information

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

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 T27 and T512 in treating HPV Persistency and HPV16-positive CIN.

Last updated: Nov. 17, 2023
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