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Clinical Trials in the USA / NCT06680232
Recruiting Phase 1

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

NCT06680232 · tracked via the Priya Life Science USA tracker
Sponsor
Precision BioSciences, Inc
Phase
Phase 1
Started
2024-11-14
Last updated
2026-08-24

Condition(s) studied

HEPATITIS B CHRONIC

Investigational drug(s) / intervention(s)

PBGENE-HBV →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (7)

FacilityCityRegionStatus
Massachusetts General Hospital/Harvard University Boston Massachusetts Recruiting
Hospital Beaujon Clichy France Recruiting
Queen Mary Hospital, The University of Hong Kong Hong Kong Hong Kong Recruiting
ICS ARENSIA Exploratory Medicine SRL Chisinau Moldova Recruiting
New Zealand Clinical Research Auckland New Zealand Recruiting
ARENSIA Exploratory Medicine Bucharest Romania Recruiting
Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital Cluj-Napoca Romania Recruiting

More Precision BioSciences, Inc. trials in the USA

PBGENE-DMD Phase 1/2a Safety and Preliminary Efficacy Study in Duchenne Muscular Dystrophy (FUNCTION-DMD) Recruiting
A Long-term Observational Study in Participants Who Have Received PBGENE-HBV Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680232 on ClinicalTrials.gov ↗ ← All trials in the USA