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Gene therapy takes on hepatitis b: first human trial launches

NCT ID NCT06680232

Disease control Sponsor: Precision BioSciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This early-stage study tests a new gene therapy called PBGENE-HBV in 45 adults with chronic hepatitis B who are already on antiviral medication. The goal is to see if the treatment is safe and can help control the virus. Participants must be in good health and have no liver scarring or other infections.

Why investors are watching

Precision BioSciences is testing PBGENE-HBV, a gene-editing treatment for chronic hepatitis B, in a small first-in-human trial with 45 participants. For a micro-cap company, this early safety and antiviral activity data will shape its value and future development path.

If it works: A positive result could show the treatment is safe and reduces hepatitis B virus levels, which would support further clinical development and strengthen the company's position in the hepatitis B field.

If it fails: A failure or delay could set back the program and hurt the company's prospects, since early-stage trials often fail to meet safety or efficacy goals.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B, chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine

    RECRUITING

    Bucharest, Romania, 021105, Romania

  • Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital

    RECRUITING

    Cluj-Napoca, Romania, 400006, Romania

  • Hospital Beaujon

    RECRUITING

    Clichy, France, 92110, France

  • ICS ARENSIA Exploratory Medicine SRL

    RECRUITING

    Chisinau, 2025, Moldova

  • Massachusetts General Hospital/Harvard University

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • New Zealand Clinical Research

    RECRUITING

    Auckland, 1010, New Zealand

  • Queen Mary Hospital, The University of Hong Kong

    RECRUITING

    Hong Kong, Hong Kong, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.