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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03057912

Enrollment

Registered

2017-02-20

Start date

2018-01-15

Completion date

2019-01-15

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papillomavirus-Related Malignant Neoplasm

Keywords

Cervical intraepithelial neoplasiaⅠ, TALEN, CRISPR/Cas9

Brief summary

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.

Detailed description

HPV persistent infection is the major causal factor of cervical intraepithelial neoplasia (CIN) and cervical cancer. The important roles of E6 and E7 playing in HPV-driven carcinogenesis make them attractive targets for therapeutic interventions. Previous evidences showed that using designated TALEN and CRISPR/Cas9 as genome editing tool could produce disruption of HPV16 and HPV18 E6/E7 DNA, significantly decreasing the expression of E6/E7, inducing cell apoptosis and inhibiting cell lines growth. This study will evaluate the safety and efficacy of TALEN-HPV E6/E7 and CRISPR/Cas9-HPV E6/E7 in treating HPV Persistency and HPV-related Cervical Intraepithelial NeoplasiaⅠ

Interventions

BIOLOGICALTALEN

TALEN gel consists of TALEN plasmid, C32-447, Poloxmer 407 and distilled water as solvent.

BIOLOGICALCRISPR/Cas9

CRISPR/Cas9 gel consists of CRISPR/Cas9 plasmid, C32-447, Poloxmer 407 and distilled water as solvent.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

open label

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with Adverse Events	6 months	The primary objective of this Study is to evaluate the safety of therapeutic doses and the dosing regimen of TALEN and CRISPR/Cas9 plasmid.

Secondary

Measure	Time frame	Description
Change of HPV16 or 18 DNA titers	Baseline, 3 and 6 months	Blood samples will be taken at the baseline, months 3 and 6 on each subject.
Change of cervical cytological results.	Baseline, 3 and 6 months	ThinPrep Pap Test will be conducted at the baseline, months 3 and 6 on each subject.
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 ContactZheng Hu, M.D.

18627803527@163.com0086+18627803527

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026