Chronic Hepatitis BPhase 1NCT05905731
Autologous T-cells Transfected With mRNA Encoding HBV-TCR T Cell Therapy in Combination With NUC for Chronic Hepatitis B
A Phase 1 study testing TCR-T in people with Chronic Hepatitis B, run by Beijing 302 Hospital at 1 site in China.
Trial summary
This is a single center, single arm, open label study to assess the safety, tolerability and effectiveness of the autologous HBV specific T cell receptor (HBV-TCR) redirected T cells in patients with chronic hepatitis B with ongoing with nucleos(t)ide analogue (NUC) treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TCR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to Jun 2026
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HBsAg Positive, HBeAg Negative, Anti-HBe Positive (with HBeAg seroconversion).
- On first-line treatment with oral nucleoside analogs antiviral drug therapy for more than a year.
- Adequate organ function
- Willing to stop and/or not to be on other immunomodulators during the study period, and to inform in time when other treatments such as glucocorticoids are needed
- Liver biopsy, Fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis (≥ Metavir 3, recommended cut-off for Fibroscan 9.0kPa)
- Females of childbearing potential must have a negative pregnancy test at Screening (within 3 days prior to first dose) and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to Screening, or who have had total hysterectomy. Willing and able to comply with all study procedures.
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
Who cannot join
- History of Acute infection, gastrointestinal bleeding, etc. occurring within 28 days prior to study enrollment.
- Advanced liver cirrhosis, Child-Pugh score ≥ 7 or clinical symptoms of liver function decompensation such as ascites and varicose veins
- Positive test for other viral infections, anti-HAV IgM, anti HCV, anti-HDV, anti -HEV and anti-HIV Any item is positive; liver disease caused by other reasons (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic liver disease, drug-induced liver disease and other liver diseases of unknown cause, etc.).
- History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) > 20 ng/mL at Screening. If AFP > 20 ng/mL, hepatic imaging must exclude hepatocellular carcinoma.
- History of having received (in the last 6 months) or currently receiving any other cell therapies
- History of organ transplantation
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- History of severe allergic reaction (hives or anaphylaxis) to blood products
- History of any Grade 4 immune-related AE from prior immunotherapy. Any immune-related AE that led to permanent discontinuation that occurred less than 6 months prior to leukapheresis or whole blood collection for production
- Use of any investigational product (IP) within 28 days of study treatment administration.
- Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Safety and Efficacy of Autologous T-cells Transfected With mRNA Encoding Hepatitis-B Virus (HBV)-Antigen-specific T Cell Receptor (TCR) in Combination With Nucleos(t)Ide Analogue (NUC) for Chronic Hepatitis B
This is a single center, single arm, open label study to assess the safety, tolerability and effectiveness of the autologous HBV specific T cell receptor (HBV-TCR) redirected T cells in patients with chronic hepatitis B with ongoing with nucleos(t)ide analogue (NUC) treatment. This study will be conducted sequentially starting with Stage-1, followed by Stage-2.
- Conditions
- Chronic Hepatitis B
- Being tested
- TCR-T
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCR-TBiological
Stage-1: Patients will receive three biweekly HBV-TCR T cell infusions at escalating doses, ranging from 1 x 10^5 cells/kg to 5 x 10^6 cells/kg bodyweight (by IV infusion). Patients are to remain on existing HBV NUC treatment.
Stage-2: Patients will receive three biweekly HBV-TCR T cell infusions at maximum dose as determined in Stage-1 study. Patients are to remain on existing HBV NUC treatment.
| Study group | Role | What they receive |
|---|---|---|
| HBV-TCR T cell infusion | Experimental | Autologous HBV specific TCR redirected T cells Receives: Biological: TCR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation of HBV-TCR T cell treatment
Incidence of adverse events/serious adverse events
Measured: Start of Treatment until 28 days post last dose
Secondary outcomes (1)
To evaluate the capability of HBV-TCR T cell treatment to lower the levels of serum HBsAg
This is based on quantitative changes of HBsAg levels from baseline
Measured: Start of treatment until 12 months post treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu-Sheng Wang, MD, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905731
- Sponsor's protocol ID
- LTCR-CHB-2-1
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Safety and Efficacy of Autologous T-cells Transfected With mRNA Encoding Hepatitis-B Virus (HBV)-Antigen-specific T Cell Receptor (TCR) in Combination With Nucleos(t)Ide Analogue (NUC) for Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT05905731
- Acronym / sponsor ID
- LTCR-CHB-2-1
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Jun 2023 (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 a single center, single arm, open label study to assess the safety, tolerability and effectiveness of the autologous HBV specific T cell receptor (HBV-TCR) redirected T cells in patients with chronic hepatitis B with ongoing with nucleos(t)ide analogue (NUC) treatment. This study will be conducted sequentially starting with Stage-1, followed by Stage-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV-TCR T cell infusion | Experimental | Biological: TCR-TAutologous HBV specific TCR redirected T cells |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HBsAg Positive, HBeAg Negative, Anti-HBe Positive (with HBeAg seroconversion).
- On first-line treatment with oral nucleoside analogs antiviral drug therapy for more than a year.
- Adequate organ function
- Willing to stop and/or not to be on other immunomodulators during the study period, and to inform in time when other treatments such as glucocorticoids are needed
- Liver biopsy, Fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis (≥ Metavir 3, recommended cut-off for Fibroscan 9.0kPa)
Key exclusion criteria (10 listed)
- History of Acute infection, gastrointestinal bleeding, etc. occurring within 28 days prior to study enrollment.
- Advanced liver cirrhosis, Child-Pugh score ≥ 7 or clinical symptoms of liver function decompensation such as ascites and varicose veins
- Positive test for other viral infections, anti-HAV IgM, anti HCV, anti-HDV, anti -HEV and anti-HIV Any item is positive; liver disease caused by other reasons (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic liver disease, drug-induced liver disease and other liver diseases of unknown cause, etc.).
- History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) > 20 ng/mL at Screening. If AFP > 20 ng/mL, hepatic imaging must exclude hepatocellular carcinoma.
- History of having received (in the last 6 months) or currently receiving any other cell therapies
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 |
|---|---|---|
| TCR-TStage-1: Patients will receive three biweekly HBV-TCR T cell infusions at escalating doses, ranging from 1 x 10^5 cells/kg to 5 x 10^6 cells/kg bodyweight (by IV infusion). Patients are to remain on existing HBV NUC treatment. Stage-2: Patients will receive three biweekly HBV-TCR T cell infusions at maximum dose as determined in Stage-1 study. Patients are to remain on existing HBV NUC treatment. | Biological | HBV-TCR T cell infusion |
Primary outcome
Safety evaluation of HBV-TCR T cell treatment
Time frame: Start of Treatment until 28 days post last dose
Incidence of adverse events/serious adverse events
1 secondary outcome
To evaluate the capability of HBV-TCR T cell treatment to lower the levels of serum HBsAg
Time frame: Start of treatment until 12 months post treatment follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
Fu-Sheng Wang, MD principal investigator
Beijing 302 Hospital
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 TCR-T in people with Chronic Hepatitis B, run by Beijing 302 Hospital 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 7 inclusion and 10 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 15 Jun 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation of HBV-TCR T cell treatment (time frame: Start of Treatment until 28 days post last dose). 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 15 Jun 2023.