A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ

First Affiliated Hospital, Sun Yat-Sen University60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Human Papillomavirus-Related Malignant Neoplasm

Interventions

TALENBIOLOGICAL

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

CRISPR/Cas9BIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of participants with Adverse Events

The primary objective of this Study is to evaluate the safety of therapeutic doses and the dosing regimen of TALEN and CRISPR/Cas9 plasmid.

Time frame: 6 months

Secondary Outcomes

Change of HPV16 or 18 DNA titers

Blood samples will be taken at the baseline, months 3 and 6 on each subject.

Time frame: Baseline, 3 and 6 months

Change of cervical cytological results.

ThinPrep Pap Test will be conducted at the baseline, months 3 and 6 on each subject.

Time frame: Baseline, 3 and 6 months

Change of cervical histological results.

Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject.

Time frame: Baseline and 6 months.

Central Contacts

Zheng Hu, M.D.

CONTACT

0086+18627803527 18627803527@163.com

Data from ClinicalTrials.gov

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