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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 1

Conditions: Human Papillomavirus-Related Malignant Neoplasm

Treatments: Biological: T512

Study type: Interventional

Funder types: Other

Identifiers

NCT03226470

2017TALEN-V02

Details and patient eligibility

About

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

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

T512 group

Experimental group

Description:

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

Treatment:

Biological: T512