Recruiting
Phase 1

PBGENE-HBV

Sponsor:

Precision BioSciences, Inc.

Code:

NCT06680232

Conditions

HEPATITIS B CHRONIC

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PBGENE-HBV

Study Details

Brief 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.

Conditions

HEPATITIS B CHRONIC

Study ID

NCT06680232

Start date

Nov 14, 2024

Status verified date

Sep, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Safety to Assess Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 4 weeks after final dose ]

Central Contacts and Locations

Central contacts

Precision Trial Manager

800-371-8953ELIMINATE-B@precisionbiosciences.com

Locations

Massachusetts General Hospital/Harvard University

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Raymond T Chung, MD

617-724-75Chung.Raymond@mgh.harvard.edu

Principal Investigator:

Raymond T Chung, MD

More Information

Sponsor

Precision BioSciences, Inc.

Last update posted

Aug 24, 2026

Last verified

Sep, 2025

Keywords

  • HEPATITIS B CHRONIC
  • Gene Therapy
  • Gene Editing
  • PBGENE-HBV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Precision BioSciences, Inc. on 2026-08-24.