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Trial record 2 of 11 for:    CRISPR | cancer | China

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057912
Recruitment Status : Unknown
Verified June 2017 by Hu Zheng, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Jingchu University of Technology
Information provided by (Responsible Party):
Hu Zheng, First Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE February 12, 2017
First Posted Date  ICMJE February 20, 2017
Last Update Posted Date June 9, 2017
Estimated Study Start Date  ICMJE January 15, 2018
Estimated Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Number of participants with Adverse Events [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03057912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Change of HPV16 or 18 DNA titers [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline and 6 months. ]
    Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Number of participants with significant reduction of HPV16 or 18 DNA titers [ Time Frame: 6 months ]
    Blood samples will be taken at the baseline, months 3 and 6.
  • Number of participants with cytological and histological regression [ Time Frame: 6 months ]
    ThinPrep Pap Test will be conducted at the baseline, months 3 and 6. Colposcopy Biopsy will be conducted at the baseline and month 6.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of TALEN and CRISPR/Cas9 in the Treatment of HPV-related Cervical Intraepithelial NeoplasiaⅠ
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
open label
Primary Purpose: Treatment
Condition  ICMJE Human Papillomavirus-Related Malignant Neoplasm
Intervention  ICMJE
  • Biological: TALEN
    TALEN gel consists of TALEN plasmid, C32-447, Poloxmer 407 and distilled water as solvent.
    Other Name: 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 Name: CRISPR/Cas9-HPV16 E6/E7T1;CRISPR/Cas9-HPV18 E6/ E7T2
Study Arms  ICMJE
  • Experimental: TALEN
    TALEN (TALEN-HPV16 E6/E7 or TALEN-HPV18 E6/E7) plasmid in gel, administered twice one week for 4 weeks.
    Intervention: Biological: TALEN
  • Experimental: CRISPR/Cas9
    CRISPR/Cas9 (CRISPR/Cas9-HPV16 E6/E7T1 or CRISPR/Cas9-HPV18 E6/E7T2 )plasmid in gel, administered twice one week for 4 weeks.
    Intervention: Biological: CRISPR/Cas9
  • No Intervention: Control group
    Observation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2019
Estimated Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057912
Other Study ID Numbers  ICMJE 2017CRISPR/Cas9&TALEN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hu Zheng, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE First Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Jingchu University of Technology
Investigators  ICMJE
Principal Investigator: Zheng Hu, M.D. First Affiliated Hospital, Sun Yat-Sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP