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Gene Therapy Trial Report

Summary

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


NCTID NCT06680232 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Chronic Hepatitis B
Disease Ontology Term DOID:2043
Compound Name PBGENE-HBV
Sponsor Precision BioSciences, Inc.
Funder Type Industry
Recruitment Status
Enrollment Count 45 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant HBV DNA
Therapy Type Gene editing
Therapy Route In-vivo
Mechanism of Action Gene inactivation
Route of Administration Intravenous
Drug Product Type LNP
Delivery System Lipid encapsulation
Vector Type LNP
Editor Type ARCUS
Dose 1 0.2mg/kg
Dose 2 0.4 mg/kg
Dose 3 0.8 mg/kg
Dose 4 🔄 0.65mg/kg

Study Record Dates


Current Stage Phase1
Submit Date 2024-10-24
Completion Date 2026-12
Last Update 2025-09-26

Participation Criteria


Eligible Age 18 Years - 70 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
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
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 4
Locations New Zealand,Hong Kong,United States,Moldova

Regulatory Information


Has US IND True
FDA Designations Fast Track
Recent Updates Cohort 5 dosing started at 0.65mg/kg, additional data readouts planned in early 2026

Resources/Links