Adoptive Treatment for Hepatitis B With γδT CellsEarly Phase 1NCT03113058
"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol
A Early Phase 1 study testing Adoptive transfer of γδT cells in people with Adoptive Treatment for Hepatitis B With γδT Cells, run by Jinan University Guangzhou at 1 site in China.
Trial summary
To evaluate the safety and anti-HBV efficacy of γδT cells. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Adoptive Treatment for Hepatitis B With γδT Cells
- What is being tested?
- Adoptive transfer of γδT cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2017to 1 Nov 2018
- Phase
- Early 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.
Who cannot join
- 1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Guagnzhou Qiaokang Hospital
Guangzhou, Guangdong
Ren X Lai, bachelor, +86-15920368701, huitou_2007@163.com
About this study
Official title: "Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol
To evaluate the safety and anti-HBV efficacy of γδT cells.
Read the detailed description
In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.
- Being tested
- Adoptive transfer of γδT cells
- Keywords
- HBV infection,γδT cells,Adoptive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adoptive transfer of γδT cellsCombination product
Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Combination Product: Adoptive transfer of γδT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA copy number
Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.
Measured: 6 months
Negative conversion rate of HbeAg
We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start2 May 2017 (estimated)
- Primary completion5 Oct 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adoptive Treatment for Hepatitis B With γδT CellsStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guagnzhou Qiaokang Hospital
- Responsible party
- Principal investigator, Zhinan Yin, Ph.D., Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113058
- Sponsor's protocol ID
- GDT-HBV-01-QK
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT03113058
- Acronym / sponsor ID
- GDT-HBV-01-QK
- Keywords
- HBV infection,γδT cells,Adoptive treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Collaborators
- Guagnzhou Qiaokang Hospital
- Study start
- 2 May 2017 (estimated)
- Primary completion
- 5 Oct 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 13 Apr 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.
To evaluate the safety and anti-HBV efficacy of γδT cells.
Detailed description
In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Combination Product: Adoptive transfer of γδT cells |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.
Key exclusion criteria (1 listed)
- 1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment
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 |
|---|---|---|
| Adoptive transfer of γδT cellsPatients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months). | Combination product | study group |
Primary outcome
DNA copy number
Time frame: 6 months
Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.
Negative conversion rate of HbeAg
Time frame: 6 months
We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adoptive transfer of γδT cells in people with Adoptive Treatment for Hepatitis B With γδT Cells, run by Jinan University Guangzhou 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 1 inclusion and 1 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 21 Apr 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Zhinan Yin, Ph.D. ((+86)18818801179, zhinan.yin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA copy number (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2017.