Trial | NCT03057912  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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 Started
Jan 15
2018
Anticipated
Primary Completion
Nov 15
2018
Anticipated
Study Completion
Jan 15
2019
Anticipated
Last Update
Jun 09
2017

Biological TALEN

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

  • Other names: TALEN-HPV16 E6/E7;TALEN-HPV18 E6/E7

Biological CRISPR/Cas9

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

  • Other names: CRISPR/Cas9-HPV16 E6/E7T1;CRISPR/Cas9-HPV18 E6/ E7T2

TALEN Experimental

TALEN (TALEN-HPV16 E6/E7 or TALEN-HPV18 E6/E7) plasmid in gel, administered twice one week for 4 weeks.

CRISPR/Cas9 Experimental

CRISPR/Cas9 (CRISPR/Cas9-HPV16 E6/E7T1 or CRISPR/Cas9-HPV18 E6/E7T2 ）plasmid in gel, administered twice one week for 4 weeks.

Control group No Intervention

Observation

Criteria 

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
No Results Posted