Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions
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|ClinicalTrials.gov Identifier: NCT03226470|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus-Related Malignant Neoplasm||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 and T512 in treating HPV Persistency and HPV16-positive CIN.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of Transcription Activator-like Effector Nucleases 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: 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Documented HPV16 infection and integration.
- Married and fertile, no fertility requirements.
- The cervical transformation zone was type I or II, and the biopsy results under colposcopy suggested SIL.
- 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): NCT03226470
|Contact: Ding Ma, M.D.||email@example.com|
|Wuhan, Hubei, China, 430030|
|Contact: Ding Ma, M.D. 86-27-83662681 firstname.lastname@example.org|
|Study Director:||Hui Wang, M.D.||Huazhong University of Science and Technology|
|Responsible Party:||Ding Ma, Head of Cancer Biology center, Huazhong University of Science and Technology|
|Other Study ID Numbers:||
|First Posted:||July 21, 2017 Key Record Dates|
|Last Update Posted:||January 14, 2022|
|Last Verified:||December 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Transcription Activator-like Effector Nucleases
cervical intraepithelial neoplasia