PBGENE-HBV for Chronic Hepatitis B
(ELIMINATE-B Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called PBGENE-HBV for individuals with chronic hepatitis B, a long-term liver infection caused by the hepatitis B virus. The main goal is to assess the safety and effectiveness of this treatment and its behavior in the body. Participants will receive varying doses to determine the optimal one. Individuals with hepatitis B who have been on stable medication and have had the infection for at least a year may be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial requires that participants are already virologically suppressed on their current NA (nucleos(t)ide analog) treatment, so you will need to continue taking your current medication for chronic hepatitis B.
Is there any evidence suggesting that PBGENE-HBV is likely to be safe for humans?
A previous study showed that early safety results for PBGENE-HBV indicated the treatment was generally well-tolerated by patients. Reports indicate that participants experienced no severe side effects. Ongoing research suggests it is safe to increase the dose and administer multiple doses. Although PBGENE-HBV remains in the early stages of testing, these findings are promising for its safety in humans. It is important to note that this treatment is still under study, and more information will become available as research progresses.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about PBGENE-HBV because it offers a new approach to treating chronic Hepatitis B. Unlike standard therapies like nucleos(t)ide analogs and pegylated interferon, which primarily work by suppressing the virus, PBGENE-HBV is delivered through multiple intravenous doses in a way that aims to reduce the viral load more effectively. This treatment could potentially lead to a more sustained response or even a functional cure, which is a significant advancement over current options that require long-term management. The innovative delivery method and potential for a finite course of treatment make PBGENE-HBV a compelling option for future Hepatitis B care.
What evidence suggests that PBGENE-HBV might be an effective treatment for chronic hepatitis B?
Research has shown that PBGENE-HBV effectively lowers the levels of a specific protein linked to chronic hepatitis B. In early studies, every participant experienced a noticeable drop in this protein after receiving PBGENE-HBV. The treatment was well-tolerated and demonstrated strong activity after three doses, indicating its potential as a promising antiviral option. Initial results revealed that two out of three patients saw a reduction in protein levels after just the first dose. This data suggests that PBGENE-HBV could be a powerful treatment for chronic hepatitis B.26789
Who Is on the Research Team?
Stanley Frankel, MD Medical Monitor
Principal Investigator
Precision BioSciences, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with chronic hepatitis B who are not able to have children, have a BMI between 18.0 and 35.0, do not have active hepatitis B e-antigen, and are currently suppressing the virus with nucleoside analogs (NA). They must be in good health as determined by the study investigator and should have documented CHB infection for at least one year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a finite course of multiple IV dose administrations of PBGENE-HBV in a dose escalation and expansion manner
Follow-up
Participants are monitored for safety and effectiveness after treatment, including antiviral activity and safety assessments
What Are the Treatments Tested in This Trial?
Interventions
- PBGENE-HBV
Trial Overview
The trial is testing PBGENE-HBV, which is being studied for its safety and ability to fight the hepatitis B virus. It's an early-stage (Phase 1) trial where participants receive increasing doses of this new treatment to see how well they tolerate it and how it affects their viral levels.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Precision BioSciences, Inc.
Lead Sponsor
Citations
1.
investor.precisionbiosciences.com
investor.precisionbiosciences.com/news-releases/news-release-details/precision-biosciences-presents-late-breaking-phase-1-pbgene-hbvPress Releases
Every participant receiving PBGENE-HBV exhibited measurable reductions in hepatitis B surface antigen (HBsAg) following treatment, confirming on ...
NCT06680232 | Phase 1 Study to Evaluate Safety and ...
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 ...
3.
investor.precisionbiosciences.com
investor.precisionbiosciences.com/news-releases/news-release-details/precision-biosciences-announces-phase-1-safety-and-efficacyPress Releases
PBGENE-HBV was both well-tolerated and highly active in all chronic hepatitis B patients after three dose administrations. The data from the ...
4.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/news/potentially-curative-gene-editing-tx-for-chronic-hbv-gets-fast-track-status/Potentially Curative Gene Editing Tx for Chronic HBV Gets ...
Initial findings from the trial showed PBGENE-HBV reduced hepatitis B surface antigen (HBsAg) in 2 of the 3 participants after the first of 3 ...
Precision BioSciences Reports Third Quarter 2025 ...
“The PBGENE-HBV data presented so far this year has shown proof of durable activity and a safety profile that allows us to continue dose ...
6.
investor.precisionbiosciences.com
investor.precisionbiosciences.com/news-releases/news-release-details/precision-biosciences-announces-presentation-initial-safety-dataPress Releases
PBGENE-HBV is Precision's first-in-class gene editing therapy for chronic hepatitis B being evaluated in the global Phase 1 ELIMINATE-B study.
7.
precisionbiosciences.com
precisionbiosciences.com/wp-content/uploads/2025/05/PBGENE-HBV_Eliminate-B_ASGCT_final.pdfInitial safety data from ELIMINATE-B, the first clinical trial of ...
These data support the continued evaluation of multiple dose administrations per dose cohort and higher dose level cohorts of PBGENE-HBV, with ...
Precision BioSciences Presents Preclinical Safety and ...
These new data highlight the potential to safely administer repeated doses of PBGENE-HBV, a LNP delivered gene editor, to achieve durable ...
Precision BioSciences Presents Late-Breaking Phase 1 ...
The presentation includes data from the ongoing ELIMINATE-B Phase 1 study evaluating PBGENE-HBV, a first-in-class in vivo gene editing therapy ...
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