Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03226470|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus-Related Malignant Neoplasm||Biological: T27 Biological: T512||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of Transcription Activator-like Effector Nucleases T27 and T512 in HPV16-infected Subjects|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||February 10, 2022|
|Estimated Study Completion Date :||June 10, 2022|
Experimental: T27 group
Subjects will receive suppository with T27 at 2 intervals for one month.
T27 suppository contain 500 µg of T27 and suppocire.
Other Name: TALEN-T27
Experimental: T512 group
Subjects will receive suppository with T512 at 2 intervals for one month.
T512 suppository contain 500 µg of T512 and suppocire.
Other Name: TALEN-T512
No Intervention: Control group
- Safety-Number of participants with Adverse Events [ Time Frame: 6 months ]Number of participants who report adverse events as a measure of safety
- Change of HPV16 DNA titers [ Time Frame: Baseline, 3 and 6 months ]Blood samples will be taken at the indicated times
- Number of dysplastic cells mearsured by ThinPrep Pap Test [ Time Frame: Baseline, 3 and 6 months ]From high-grade squamous intraepithelial lesion (HSIL) to Low-grade Squamous Intraepithelial Lesion (LSIL), or from LSIL to negative
- 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
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): NCT03226470
|Contact: Ding Ma, M.D.||firstname.lastname@example.org|
|Wuhan, Hubei, China, 430030|
|Contact: Ding Ma, M.D. 86-27-83662681 email@example.com|
|Study Director:||Hui Wang, M.D.||Huazhong University of Science and Technology|