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 : Unknown
Verified June 2017 by Hu Zheng, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : June 9, 2017
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|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.
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Documented HPV16 or HPV18 infection.
- Married and fertile, no fertility requirements.
- Without administration of hormone in the last six months.
- Subjects must be meet the ethical requirements and have signed informed consent.
- Pregnancy and breast feeding
- Any bacterial vaginitis
- Any Fungal vaginitis
- Any sexually transmitted diseases
- Active drug or alcohol abuse
- Any HPV medications within the past 12 weeks
- Allergy to active or non active ingredients in the study of drugs
- Cardiac insufficiency
- Liver and renal insufficiency
- Hypertension and severe complications
- Serious illness in past 30 days
- Currently participating in another clinical trial or any prior gene therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057912
|Contact: Zheng Hu, M.D.||firstname.lastname@example.org|
|The First Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Contact: Zheng Hu, M.D. 0086+18627803527 email@example.com|
|Principal Investigator:||Zheng Hu, M.D.||First Affiliated Hospital, Sun Yat-Sen University|
|Responsible Party:||Hu Zheng, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University|
|Other Study ID Numbers:||
|First Posted:||February 20, 2017 Key Record Dates|
|Last Update Posted:||June 9, 2017|
|Last Verified:||June 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Cervical intraepithelial neoplasiaⅠ