Phase 1 Study of PBGENE-HBV for Chronic Hepatitis B

This study is testing a new treatment called PBGENE-HBV for adults with chronic hepatitis B (a long-lasting liver infection). PBGENE-HBV is designed to potentially cure chronic hepatitis B by targeting and removing the virus's genetic material from liver cells. We are looking for adults aged 18 to 70 who have chronic hepatitis B, are in good overall health, and are currently taking medication for their condition. You must also be HBeAg-negative and have no history of cirrhosis (severe liver scarring). The main goal of this study is to check the safety of PBGENE-HBV and see if it causes any side effects. The current recruitment status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 45 participants to evaluate different doses of PBGENE-HBV.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be assessed for 4 weeks after your final dose of PBGENE-HBV.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06680232

Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Precision BioSciences, Inc.
~45 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:PBGENE-HBV

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Measured over 4 weeks after final dose
HEPATITIS B CHRONIC
7 sites across 6 states
Romania2
Massachusetts1
France1
Hong Kong1
Moldova1
New Zealand1
  • Oby Sogbetun Medical Monitor, MD · STUDY_DIRECTOR · Precision BioSciences, Inc.

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Safety to Assess Treatment-emergent Adverse Events (TEAEs)4 weeks after final dose

    Frequency of TEAEs