Human Papillomavirus-Related Malignant Neoplasm Clinical Trial
Official title:
Safety Study of Transcription Activator-like Effector Nucleases T512 in HPV16-infected Subjects
This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 10, 2022 |
Est. primary completion date | February 10, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Huazhong University of Science and Technology |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety-Number of participants with Adverse Events | Number of participants who report adverse events as a measure of safety | 6 months | |
Secondary | Change of HPV16 DNA titers | Blood samples will be taken at the indicated times | Baseline, 3 and 6 months | |
Secondary | Number of dysplastic cells mearsured by ThinPrep Pap Test | From high-grade squamous intraepithelial lesion (HSIL) to Low-grade Squamous Intraepithelial Lesion (LSIL), or from LSIL to negative | Baseline, 3 and 6 months | |
Secondary | Change of cervical histological results | Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject | Baseline and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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