Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
NCT ID: NCT06680232
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
45 participants
INTERVENTIONAL
2024-11-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Precision BioSciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stanley Frankel, MD Medical Monitor
Role: STUDY_DIRECTOR
Precision BioSciences, Inc.
Locations
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Massachusetts General Hospital/Harvard University
Boston, Massachusetts, United States
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
ICS ARENSIA Exploratory Medicine SRL
Chisinau, , Moldova
New Zealand Clinical Research
Auckland, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PBGENE-HBV-01
Identifier Type: -
Identifier Source: org_study_id
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