Study of Targeted Therapy Using Transcription Activator-l... | NCT03226470

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

NCT03226470

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Jan 14, 2022Actual

Enrollment

40Estimated

Phase

Phase 1

Conditions

Human Papillomavirus-Related Malignant Neoplasm

Interventions

T512

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2017Actual

Primary Completion Date

Feb 10, 2022Estimated

Completion Date

Jun 10, 2022Estimated

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2021

Last Update Posted Date

Jan 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ding Ma, Head of Cancer Biology center, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T512 group	Experimental	Subjects will receive suppository with T512 at 2 intervals for one month.	Biological: T512

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T512	Biological	T512 suppository contain 500 µg of T512 and suppocire.	T512 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety-Number of participants with Adverse Events	Number of participants who report adverse events as a measure of safety	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change of HPV16 DNA titers	Blood samples will be taken at the indicated times	Baseline, 3 and 6 months
Number of dysplastic cells mearsured by ThinPrep Pap Test	From high-grade squamous intraepithelial lesion (HSIL) to Low-grade Squamous Intraepithelial Lesion (LSIL), or from LSIL to negative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ding Ma, M.D.	Contact	86-27-83662681		dma@tjh.tjmu.edu.cn

Overall Officials

Name	Affiliation	Role
Hui Wang, M.D.	Huazhong University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital	Recruiting	Wuhan	Hubei	430030	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25500889	Background	Hu Z, Ding W, Zhu D, Yu L, Jiang X, Wang X, Zhang C, Wang L, Ji T, Liu D, He D, Xia X, Zhu T, Wei J, Wu P, Wang C, Xi L, Gao Q, Chen G, Liu R, Li K, Li S, Wang S, Zhou J, Ma D, Wang H. TALEN-mediated targeting of HPV oncogenes ameliorates HPV-related cervical malignancy. J Clin Invest. 2015 Jan;125(1):425-36. doi: 10.1172/JCI78206. Epub 2014 Dec 15.

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases