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Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226470
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Brief Summary:
This is an open-label and triple cohort study of the safety and efficacy of T27 and T512 to possibly treat cervical intraepithelial neoplasia(CIN).

Condition or disease Intervention/treatment Phase
Human Papillomavirus-Related Malignant Neoplasm Biological: T27 Biological: T512 Phase 1

Detailed Description:

Persistent infection with high-risk human papillomavirus (HPVs),especially types 16 and 18,may lead to cervical intraepithelial neoplasia(CIN).HPVs expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies showed that using designated TALENs (T27 and T512) targeted HPV16 E6 and E7 produced disruption of HPV16 E6 and E7 DNA, decreased the expression of E6 and E7 proteins, and induced cell apoptosis.

This study will evaluate the safety and efficacy of T27 and T512 in treating HPV Persistency and HPV16-positive CIN.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Transcription Activator-like Effector Nucleases T27 and T512 in HPV16-infected Subjects
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : February 10, 2022
Estimated Study Completion Date : June 10, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: T27 group
Subjects will receive suppository with T27 at 2 intervals for one month.
Biological: T27
T27 suppository contain 500 µg of T27 and suppocire.
Other Name: TALEN-T27

Experimental: T512 group
Subjects will receive suppository with T512 at 2 intervals for one month.
Biological: T512
T512 suppository contain 500 µg of T512 and suppocire.
Other Name: TALEN-T512

No Intervention: Control group
Observation



Primary Outcome Measures :
  1. Safety-Number of participants with Adverse Events [ Time Frame: 6 months ]
    Number of participants who report adverse events as a measure of safety


Secondary Outcome Measures :
  1. Change of HPV16 DNA titers [ Time Frame: Baseline, 3 and 6 months ]
    Blood samples will be taken at the indicated times

  2. Number of dysplastic cells mearsured by ThinPrep Pap Test [ Time Frame: Baseline, 3 and 6 months ]
    From high-grade squamous intraepithelial lesion (HSIL) to Low-grade Squamous Intraepithelial Lesion (LSIL), or from LSIL to negative

  3. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226470


Contacts
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Contact: Ding Ma, M.D. 86-27-83662681 dma@tjh.tjmu.edu.cn

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Ding Ma, M.D.    86-27-83662681    dma@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Study Director: Hui Wang, M.D. Huazhong University of Science and Technology
Publications:
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Responsible Party: Ding Ma, Head of Cancer Biology center, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03226470    
Other Study ID Numbers: 2017TALEN-V02
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ding Ma, Huazhong University of Science and Technology:
Transcription Activator-like Effector Nucleases
Human papillomavirus
cervical intraepithelial neoplasia
Additional relevant MeSH terms:
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Neoplasms