Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions
Safety Study of Transcription Activator-like Effector Nucleases T512 in HPV16-infected Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2017
CompletedFirst Submitted
Initial submission to the registry
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2022
CompletedJanuary 14, 2022
December 1, 2021
4.9 years
July 17, 2017
December 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety-Number of participants with Adverse Events
Number of participants who report adverse events as a measure of safety
6 months
Secondary Outcomes (3)
Change of HPV16 DNA titers
Baseline, 3 and 6 months
Number of dysplastic cells mearsured by ThinPrep Pap Test
Baseline, 3 and 6 months
Change of cervical histological results
Baseline and 6 months
Study Arms (1)
T512 group
EXPERIMENTALSubjects will receive suppository with T512 at 2 intervals for one month.
Interventions
T512 suppository contain 500 µg of T512 and suppocire.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
Related Publications (1)
Hu Z, Ding W, Zhu D, Yu L, Jiang X, Wang X, Zhang C, Wang L, Ji T, Liu D, He D, Xia X, Zhu T, Wei J, Wu P, Wang C, Xi L, Gao Q, Chen G, Liu R, Li K, Li S, Wang S, Zhou J, Ma D, Wang H. TALEN-mediated targeting of HPV oncogenes ameliorates HPV-related cervical malignancy. J Clin Invest. 2015 Jan;125(1):425-36. doi: 10.1172/JCI78206. Epub 2014 Dec 15.
PMID: 25500889BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hui Wang, M.D.
Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cancer Biology center
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 21, 2017
Study Start
March 10, 2017
Primary Completion
February 10, 2022
Study Completion
June 10, 2022
Last Updated
January 14, 2022
Record last verified: 2021-12