Human Papillomavirus-Related Malignant Neoplasm
Conditions
Keywords
Transcription Activator-like Effector Nucleases, Human papillomavirus, cervical intraepithelial neoplasia
Brief summary
This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
Detailed description
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.
Interventions
BIOLOGICALT512
T512 suppository contain 500 µg of T512 and suppocire.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety-Number of participants with Adverse Events | 6 months | Number of participants who report adverse events as a measure of safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of HPV16 DNA titers | Baseline, 3 and 6 months | Blood samples will be taken at the indicated times |
| Number of dysplastic cells mearsured by ThinPrep Pap Test | 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 | Baseline and 6 months | Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject |
Countries
China
Contacts
Primary ContactDing Ma, M.D.
Outcome results
None listed