Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients with Chronic Hepatitis B (ELIMINATE-B)

Precision BioSciences

Status and phase: Enrolling; Phase 1

Conditions: HEPATITIS B CHRONIC

Treatments: Biological: PBGENE-HBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT06680232

PBGENE-HBV-01

Details and patient eligibility

About

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.

Full description

Refer to key Inclusion and Exclusion criteria.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.

Experimental group

Description:

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.

Treatment:

Biological: PBGENE-HBV