Mass General - Division of Clinical Research

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

Arm	Description	Assigned 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.