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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2022-06-10

Brief Summary

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This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).

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Detailed Description

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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 and T512 in treating HPV Persistency and HPV16-positive CIN.

Conditions

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Human Papillomavirus-Related Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T512 group

Subjects will receive suppository with T512 at 2 intervals for one month.

Group Type EXPERIMENTAL

T512

Intervention Type BIOLOGICAL

T512 suppository contain 500 µg of T512 and suppocire.

Interventions

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T512

T512 suppository contain 500 µg of T512 and suppocire.

Intervention Type BIOLOGICAL

Other Intervention Names

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TALEN-T512

Eligibility Criteria

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Inclusion Criteria

* Documented HPV16 infection and integration.
* Married and fertile, no fertility requirements.
* The cervical transformation zone was type I or II, and the biopsy results under colposcopy suggested SIL.
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No