Clinical trial · Interventional
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
NCT03226470CI-TRIAL-00055989unknownPhase 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 single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
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 |
|---|---|---|---|
| T512 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- T512 group
- description
- Subjects will receive suppository with T512 at 2 intervals for one month.
- interventionNames
- Biological: T512
Primary outcomes (1)
- measure
- Safety-Number of participants with Adverse Events
- timeFrame
- 6 months
- description
- Number of participants who report adverse events as a measure of safety
Secondary outcomes (3)
- measure
- Change of HPV16 DNA titers
- timeFrame
- Baseline, 3 and 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (1)
- 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