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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
Drug Product 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 ๐Ÿ”„ HBV cccDNA
Therapeutic Modality Gene editing
Therapy Route in vivo
Mechanism of Action Gene inactivation
Route of Administration Intravenous
Drug Product Type ๐Ÿ”„ Encapsulated mRNA
Gene Delivery System Type ๐Ÿ”„ Endocytosis
Non-Viral Vector Type LNP
Editor Type ARCUS
Dose 1 ๐Ÿ”„ 0.2mg/kg (n=3)
Dose 2 ๐Ÿ”„ 0.4 mg/kg (n=6)
Dose 3 ๐Ÿ”„ 0.8 mg/kg (n=3)
Dose 4 ๐Ÿ”„ 0.65mg/kg (n=4)

Study Record Dates


Current Phase Phase1
Submit Date 2024-10-24
Completion Date ๐Ÿ”„ 2027-06
Last Update ๐Ÿ”„ 2026-08-24

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 ๐Ÿ”„ 7
Locations ๐Ÿ”„ New Zealand,Romania,Hong Kong,United States,Moldova,France

Regulatory Information


Has US IND True
FDA Designations Fast Track
Recent Updates New data readout in May 2026, Sponsor expected additional updates by the end of 2026

Resources/Links