Human Papillomavirus-Related Malignant NeoplasmPhase 1NCT03226470
Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions
A Phase 1 study testing T512 in people with Human Papillomavirus-Related Malignant Neoplasm, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Human Papillomavirus-Related Malignant Neoplasm
- What is being tested?
- T512
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2017to 10 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Ding Ma, M.D., 86-27-83662681, dma@tjh.tjmu.edu.cn
About this study
Official title: Safety Study of Transcription Activator-like Effector Nucleases T512 in HPV16-infected Subjects
This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
Read the 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.
- Being tested
- T512
- Keywords
- Transcription Activator-like Effector Nucleases, Human papillomavirus, cervical intraepithelial neoplasia
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T512Biological
Also called TALEN-T512
T512 suppository contain 500 µg of T512 and suppocire.
| Study group | Role | What they receive |
|---|---|---|
| T512 group | Experimental | Subjects will receive suppository with T512 at 2 intervals for one month. Receives: Biological: T512 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-Number of participants with Adverse Events
Number of participants who report adverse events as a measure of safety
Measured: 6 months
Secondary outcomes (3)
Change of HPV16 DNA titers
Blood samples will be taken at the indicated times
Measured: 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
Measured: Baseline, 3 and 6 months
Change of cervical histological results
Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start10 Mar 2017
- Primary completion10 Feb 2022 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus-Related Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Hui Wang, M.D., Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226470
- Sponsor's protocol ID
- 2017TALEN-V02
- Status last verified
- Dec 2021
- First submitted
- 17 Jul 2017
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25500889
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Transcription Activator-like Effector Nucleases T512 in HPV16-infected Subjects
- ClinicalTrials.gov ID
- NCT03226470
- Acronym / sponsor ID
- 2017TALEN-V02
- Keywords
- Transcription Activator-like Effector Nucleases, Human papillomavirus, cervical intraepithelial neoplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T512 group | Experimental | Biological: T512Subjects will receive suppository with T512 at 2 intervals for one month. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Pregnancy and breast feeding
- Any bacterial vaginitis
- Any Fungal vaginitis
- Any sexually transmitted diseases
- Active drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T512Also: TALEN-T512T512 suppository contain 500 µg of T512 and suppocire. | Biological | T512 group |
Primary outcome
Safety-Number of participants with Adverse Events
Time frame: 6 months
Number of participants who report adverse events as a measure of safety
3 secondary outcomes
Change of HPV16 DNA titers
Time frame: Baseline, 3 and 6 months
Number of dysplastic cells mearsured by ThinPrep Pap Test
Time frame: Baseline, 3 and 6 months
Change of cervical histological results
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 25500889Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Wang, M.D. study director
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T512 in people with Human Papillomavirus-Related Malignant Neoplasm, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ding Ma, M.D. (86-27-83662681, dma@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety-Number of participants with Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.