A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ
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|ClinicalTrials.gov Identifier: NCT03057912|
Recruitment Status : Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus-Related Malignant Neoplasm||Biological: TALEN Biological: CRISPR/Cas9||Phase 1|
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.
This study will evaluate the safety and efficacy of TALEN-HPV E6/E7 and CRISPR/Cas9-HPV E6/E7 in treating HPV Persistency and HPV-related Cervical Intraepithelial NeoplasiaⅠ
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|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|
|Estimated Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||November 15, 2018|
|Estimated Study Completion Date :||January 15, 2019|
TALEN (TALEN-HPV16 E6/E7 or TALEN-HPV18 E6/E7) plasmid in gel, administered twice one week for 4 weeks.
TALEN gel consists of TALEN plasmid, C32-447, Poloxmer 407 and distilled water as solvent.
Other Name: TALEN-HPV16 E6/E7;TALEN-HPV18 E6/E7
CRISPR/Cas9 (CRISPR/Cas9-HPV16 E6/E7T1 or CRISPR/Cas9-HPV18 E6/E7T2 ）plasmid in gel, administered twice one week for 4 weeks.
CRISPR/Cas9 gel consists of CRISPR/Cas9 plasmid, C32-447, Poloxmer 407 and distilled water as solvent.
Other Name: CRISPR/Cas9-HPV16 E6/E7T1;CRISPR/Cas9-HPV18 E6/ E7T2
No Intervention: Control group
- Number of participants with Adverse Events [ Time Frame: 6 months ]The primary objective of this Study is to evaluate the safety of therapeutic doses and the dosing regimen of TALEN and CRISPR/Cas9 plasmid.
- Change of HPV16 or 18 DNA titers [ Time Frame: Baseline, 3 and 6 months ]Blood samples will be taken at the baseline, months 3 and 6 on each subject.
- Change of cervical cytological results. [ Time Frame: Baseline, 3 and 6 months ]ThinPrep Pap Test will be conducted at the baseline, months 3 and 6 on each subject.
- Change of cervical histological results. [ Time Frame: Baseline and 6 months. ]Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057912
|Contact: Zheng Hu, M.D.||email@example.com|
|The First Affiliated Hospital of Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Zheng Hu, M.D. 0086+18627803527 firstname.lastname@example.org|
|Principal Investigator:||Zheng Hu, M.D.||First Affiliated Hospital, Sun Yat-Sen University|