Clinical trial · Interventional
A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ
A Safety and Efficacy Study of Transcription Activator-like Effector Nucleases and Clustered Regularly Interspaced Short Palindromic Repeat/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ
NCT03057912CI-TRIAL-00028066unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 is an open-label and triple cohort study of the safety and efficacy of TALEN and CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial neoplasiaⅠwithout invasion.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRISPR/Cas9 | Biological | — | UNRESOLVED |
| TALEN | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- TALEN
- description
- TALEN (TALEN-HPV16 E6/E7 or TALEN-HPV18 E6/E7) plasmid in gel, administered twice one week for 4 weeks.
- interventionNames
- Biological: TALEN
- type
- EXPERIMENTAL
- label
- CRISPR/Cas9
- description
- CRISPR/Cas9 (CRISPR/Cas9-HPV16 E6/E7T1 or CRISPR/Cas9-HPV18 E6/E7T2 ）plasmid in gel, administered twice one week for 4 weeks.
- interventionNames
- Biological: CRISPR/Cas9
- type
- NO_INTERVENTION
- label
- Control group
- description
- Observation
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 trial or any prior gene therapy
References
Publications (2)
- BACKGROUNDHu Z, Yu L, Zhu D, Ding W, Wang X, Zhang C, Wang L, Jiang X, Shen H, He D, Li K, Xi L, Ma D, Wang H. Disruption of HPV16-E7 by CRISPR/Cas system induces apoptosis and growth inhibition in HPV16 positive human cervical cancer cells. Biomed Res Int. 2014;2014:612823. doi: 10.1155/2014/612823. Epub 2014 Jul 20. PMID 25136604
- BACKGROUNDHu 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 25500889