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

Purpose

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.

Condition

  • HEPATITIS B CHRONIC

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

Massachusetts General Hospital/Harvard University
Boston 4930956, Massachusetts 6254926 02114
Contact:
Raymond T Chung, MD
617-724-75
Chung.Raymond@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Precision BioSciences, Inc.

Study Contact

Precision Trial Manager
800-371-8953
ELIMINATE-B@precisionbiosciences.com

Detailed Description

Refer to key Inclusion and Exclusion criteria.