HEPATITIS B CHRONICPhase 1ELIMINATE-BNCT06680232
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
A Phase 1 study testing PBGENE-HBV in people with HEPATITIS B CHRONIC, run by Precision BioSciences, Inc. at 7 sites in 6 countries.
Trial summary
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HEPATITIS B CHRONIC
- What is being tested?
- PBGENE-HBV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 14 Nov 2024to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or women of non-child bearing potential
- BMI 18.0 to 35.0
- Good overall health deemed by the study Investigator
- CHB infection documented at least 12 months prior to screening
- HBeAg-negative CHB
- Must be virologically suppressed on current NA treatment
Who cannot join
- No history of cirrhosis of the liver
- No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
- No signs of hepatocellular carcinoma
- Not received an organ transplant
- No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
- No investigational agent received within 6 months of screening
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Romania2 sites, 2 recruiting
- Recruiting
ARENSIA Exploratory Medicine
Bucharest, Romania, 021105
Anca Streinu Cercel, MD, 40722998425, anca.streinucercel@gmail.com
Coralia-Alexandra Caluian, 40727193218, coralia.caluian@arensia-em.com
- Recruiting
Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital
Cluj-Napoca, Romania, 400006
Vlad-Andrei Ichim, MD, 40751130280, vlad.ichim.ext@arensia-em.com
Emanuela Beni, 40711912839, emanuela.beni@arensia-em.com
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital/Harvard University
Boston, Massachusetts, 02114
Raymond T Chung, MD, 617-724-75, Chung.Raymond@mgh.harvard.edu
Raymond T Chung, MD
France1 site, 1 recruiting
- Recruiting
Hospital Beaujon
Clichy, France, 92110
Tarik Asselah, MD, 33140875514, tarik.asselah@aphp.fr
Stephanie Narguet, 33140875514, stephanie.narguet@aphp.fr
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Man-Fung Yuen, MBBS, MD, PhD, DSc, 852-2255 3579, mfyuen@hku.hk
Man-Fung Yuen, MBBS, MD, PhD, DSc
Moldova1 site, 1 recruiting
- Recruiting
ICS ARENSIA Exploratory Medicine SRL
Chisinau, 2025
Manager, Projects & Research Logistics, 373-78883368, alexei.haceatrean@arensia-em.com
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Auckland, 1010
Edward Gane, MD, 64-2-154-8371, EdGane@adhb.govt.nz
Sophie Townshend, Study Coordinator, 64-9-373-3474, sophie.townshend@nzcr.co.nz
About this study
Official title: A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
Read the detailed description
Refer to key Inclusion and Exclusion criteria.
- Conditions
- HEPATITIS B CHRONIC
- Being tested
- PBGENE-HBV
- Keywords
- HEPATITIS B CHRONIC, Gene Therapy, Gene Editing, PBGENE-HBV
- 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.
PBGENE-HBVBiological
PBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.
| Study group | Role | What they receive |
|---|---|---|
| Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. | Experimental | All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort. Receives: Biological: PBGENE-HBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Frequency of TEAEs
Measured: 4 weeks after final dose
Secondary outcomes (7)
Additional Safety
Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
Measured: 48 weeks
Pharmacokinetics of AUC
Total PBGENE-HBV exposure over time
Measured: 4 weeks
Pharmacokinetics of Cmax
Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
Measured: 4 weeks
Pharmacokinetics of Cmin
Minimum (or trough) concentration of PBGENE-HBV
Measured: 4 weeks
Pharmacokinetics of half life (t1/2)
Terminal half life
Measured: 4 weeks
Antiviral Activity of HBsAg and Anti-HBs
Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
Measured: 48 weeks
Antiviral Activity of HBV DNA
Changes from baseline of HBV DNA
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start14 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS B CHRONICStudies 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
- Sequential
- Model description
- Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oby Sogbetun Medical Monitor, MD, Study director, Precision BioSciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680232
- Sponsor's protocol ID
- PBGENE-HBV-01
- Acronym
- ELIMINATE-B
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)
- ClinicalTrials.gov ID
- NCT06680232
- Acronym / sponsor ID
- ELIMINATE-B / PBGENE-HBV-01
- Conditions
- HEPATITIS B CHRONIC
- Keywords
- HEPATITIS B CHRONIC, Gene Therapy, Gene Editing, PBGENE-HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Precision BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Nov 2024 (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 Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
Detailed description
Refer to key Inclusion and Exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.
| Arm | Type | Receives |
|---|---|---|
| Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. | Experimental | Biological: PBGENE-HBVAll participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or women of non-child bearing potential
- BMI 18.0 to 35.0
- Good overall health deemed by the study Investigator
- CHB infection documented at least 12 months prior to screening
- HBeAg-negative CHB
Key exclusion criteria (6 listed)
- No history of cirrhosis of the liver
- No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
- No signs of hepatocellular carcinoma
- Not received an organ transplant
- No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
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 |
|---|---|---|
| PBGENE-HBVPBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes. | Biological | Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. |
Primary outcome
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Time frame: 4 weeks after final dose
Frequency of TEAEs
7 secondary outcomes
Additional Safety
Time frame: 48 weeks
Pharmacokinetics of AUC
Time frame: 4 weeks
Pharmacokinetics of Cmax
Time frame: 4 weeks
Pharmacokinetics of Cmin
Time frame: 4 weeks
Pharmacokinetics of half life (t1/2)
Time frame: 4 weeks
Antiviral Activity of HBsAg and Anti-HBs
Time frame: 48 weeks
Antiviral Activity of HBV DNA
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Oby Sogbetun Medical Monitor, MD study director
Precision BioSciences, Inc.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBGENE-HBV in people with HEPATITIS B CHRONIC, run by Precision BioSciences, Inc. at 7 sites in 6 countries.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Romania, United States, France, Hong Kong, Moldova and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Precision Trial Manager (800-371-8953, ELIMINATE-B@precisionbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety to Assess Treatment-emergent Adverse Events (TEAEs) (time frame: 4 weeks after final 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 24 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.