A Phase 1 interventional study of PBGENE-HBV in HEPATITIS B CHRONIC, sponsored by Precision BioSciences, Inc.. Recruiting at 7 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Precision BioSciences, Inc. · Phase 1, Interventional, and Treatment
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.
Refer to key Inclusion and Exclusion criteria.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 45 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Precision BioSciences, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: PBGENE-HBV
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.
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Frequency of TEAEs
Time frame: 4 weeks after final dose
Additional Safety
Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
Time frame: 48 weeks
Pharmacokinetics of AUC
Total PBGENE-HBV exposure over time
Time frame: 4 weeks
Pharmacokinetics of Cmax
Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
Time frame: 4 weeks
Pharmacokinetics of Cmin
Minimum (or trough) concentration of PBGENE-HBV
Time frame: 4 weeks
Pharmacokinetics of half life (t1/2)
Terminal half life
Time frame: 4 weeks
Antiviral Activity of HBsAg and Anti-HBs
Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
Time frame: 48 weeks
Antiviral Activity of HBV DNA
Changes from baseline of HBV DNA
Time frame: 48 weeks
Plan to share: No
No publications or documents are linked to this record.
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Precision BioSciences, Inc.