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

  • STATUS
    Recruiting
  • End date
    Jun 10, 2022
  • participants needed
    40
  • sponsor
    Huazhong University of Science and Technology
Updated on 5 February 2021

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).

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.

Details
Condition Human Papillomavirus-Related Malignant Neoplasm, Human Papillomavirus-Related Malignant Neoplasm
Treatment T27, T512
Clinical Study IdentifierNCT03226470
SponsorHuazhong University of Science and Technology
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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