Clinical trial · Interventional
Study of Molecular-targeted Therapy Using Zinc Finger Nuclease in Cervical Precancerous Lesions
Safety Study of Zinc Finger Nucleases ZFN-602 and ZFN-758 in HPV-infected Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is being carried out to study a new way to possibly treat human cervical intraepithelial neoplasia (CIN) without invasion. Persistent infection with specific types of human papillomavirus (HPV, most frequently types 16 and 18) may lead to precancerous lesions(CIN). If untreated, these lesions may progress to cervical cancer within many years. In the infected cells, HPV expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies has demonstrated that E7 alone, but not E6, is sufficient to immortalize human keratinocytes in vitro and induce high-grade cervical dysplasia in a transgenic mouse model. These data indicated that E7 may dominate the malignant progress in HPV-infected cells. The agents zinc finger nucleases (ZFNs), called ZFN-603 and ZFN-758, which can cleave the HPV16 and HPV18 E7 oncogene specifically. ZFN-mediated disruption of HPV16 and HPV18 E7 DNA directly decreased the expression of E7, induced type-specific apoptosis in HPV16- and HPV18-positive cells, and inhibited cell growth. The purpose of this study is to determine whether ZFN-603 and ZFN-758 are effective in the treatment of HPV16- and HPV18-positive cervical intraepithelial neoplasia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus-Related Malignant Neoplasm | Human Papillomavirus-Related Malignant Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZFN-603 and ZFN-758 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZFN-603 and ZFN-758
- description
- Subjects will receive suppository with ZFN-603 or ZFN-758
- interventionNames
- Biological: ZFN-603 and ZFN-758
Primary outcomes (1)
- measure
- Safety - Treatment related adverse events of ZFN-603 in HPV16-positive subjects, related adverse events of ZFN-758 in HPV18-positive subjects
- timeFrame
- 6 months
- description
- Number of participants who report adverse events as a measure of safety
Secondary outcomes (3)
- measure
- Evaluate persistence of HPV16 and HPV18 as measured by HPV DNA
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Documented HPV16 or HPV18 infection. * Married and fertile, no fertility requirements. * 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 trail or any prior gene therapy
References
Publications (1)
- BACKGROUNDDing W, Hu Z, Zhu D, Jiang X, Yu L, Wang X, Zhang C, Wang L, Ji T, Li K, He D, Xia X, Liu D, Zhou J, Ma D, Wang H. Zinc finger nucleases targeting the human papillomavirus E7 oncogene induce E7 disruption and a transformed phenotype in HPV16/18-positive cervical cancer cells. Clin Cancer Res. 2014 Dec 15;20(24):6495-503. doi: 10.1158/1078-0432.CCR-14-0250. Epub 2014 Oct 21. PMID 25336692