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Monoclonal Antibodies

IMC-I109V for Chronic Hepatitis B

Phase 1
Recruiting
Research Sponsored by Immunocore Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the last infusion of study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests IMC-I109V, a new treatment that helps the immune system fight hepatitis B. It targets people with chronic hepatitis B who are receiving ongoing antiviral therapy. The treatment works by guiding the immune system to find and attack the virus.

Who is the study for?
This trial is for adults over 18 with non-cirrhotic, HBeAg-negative chronic hepatitis B who've been on entecavir/tenofovir for at least a year and are HBV DNA negative. They must be HLA-A*02:01 positive without significant heart issues, immunosuppression, or co-infection with HIV/HCV/HDV. Pregnant/lactating individuals and those with recent substance abuse or other conditions that could affect the study are excluded.
What is being tested?
The trial tests IMC-I109V in two forms: single ascending dose and multiple ascending doses. It's an ImmTAV® therapeutic designed to mobilize immune T cells against viruses, specifically targeting chronic hepatitis B virus (HBV) infection.
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to monoclonal antibodies such as infusion-related reactions, fatigue, allergic responses, or autoimmune-like symptoms due to immune system activation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after the last infusion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the last infusion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Parts 1, 2, and 3: Change in safety laboratory parameters
Parts 1, 2, and 3: Changes in Vital Signs
Parts 1, 2, and 3: Changes in electrocardiogram

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: HBV HCC Module MADExperimental Treatment1 Intervention
Enrollment into Part 3 may begin at the discretion of the Sponsor and will involve a maximum 42-day screening period, a treatment period comprising weekly administration of the target dose until the criteria for treatment discontinuation are met. Visits will take place on Day 1-2 and Day 8, Week 3 (Day 15), with this cycle being repeated until treatment stops, then 30 and 90 days post-last dose, then every 3 months after last dose, after which there will be a safety follow-up period of 30 days.
Group II: Part 2: Multiple Ascending Doses (MAD)Experimental Treatment1 Intervention
MAD will be approximately 54 weeks for each participant, comprising a maximum 42-day screening period, a 24-week treatment period involving weekly administration of IMC-I109V, and a 24-week follow-up period, with a total of 29 visits. Visits will take place on Day -1 and Days 1, 3 and 8, Weeks 3 (Day 15) through 24, Weeks 28, 36, 48 and 49. Participants who have achieved HBsAg \<100 IU/mL at end of Week 24 may be considered for further study treatments of up to Week 48 and follow-up visits every 12 weeks to Week 72. Treatment will be discontinued at Week 16 in participants who have not shown evidence of a response to IMC-I109V, in order to minimize unnecessary drug exposure in participants who are unlikely to achieve reductions in viral biomarkers with further doses.
Group III: Part 1: Single Ascending Dose (SAD)Experimental Treatment1 Intervention
SAD will be approximately 10 weeks for each participant, comprising a maximum 42-day screening period, a 1-day treatment period involving a single administration of IMC-I109V and a 28-day follow-up period, for a total of 8 visits. Visits will take place on Day -1 and Days 1, 2, 3, 8, 15, 22, and 29. Follow-up may be extended in participants who achieve a decrease in HBsAg of \> 0.5 log10 IU/mL at Day 29.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Hepatitis B (CHB) include nucleos(t)ide analogs such as entecavir and tenofovir, which inhibit viral replication by targeting the viral polymerase enzyme, and pegylated interferon, which boosts the immune response to help clear the virus. Emerging therapies like IMC-I109V, an immune-mobilizing monoclonal T cell receptor (TCR) against viruses, represent a novel approach by specifically targeting and activating T cells to recognize and destroy HBV-infected cells. This is particularly important for CHB patients as it aims to restore the immune system's ability to control the infection, potentially leading to a functional cure and reducing the need for lifelong antiviral therapy.
Defective T-cell immunity in hepatitis B virus infection: why therapeutic vaccination needs a helping hand.Current and future antiviral drug therapies of hepatitis B chronic infection.Emerging antivirals for the treatment of hepatitis B.

Find a Location

Who is running the clinical trial?

Immunocore LtdLead Sponsor
15 Previous Clinical Trials
3,796 Total Patients Enrolled
Lucy DorrellStudy DirectorImmunocore Ltd
2 Previous Clinical Trials
51 Total Patients Enrolled

Media Library

IMC-I109V (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05867056 — Phase 1
Chronic Hepatitis B Research Study Groups: Part 2: Multiple Ascending Doses (MAD), Part 3: HBV HCC Module MAD, Part 1: Single Ascending Dose (SAD)
Chronic Hepatitis B Clinical Trial 2023: IMC-I109V Highlights & Side Effects. Trial Name: NCT05867056 — Phase 1
IMC-I109V (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867056 — Phase 1
Chronic Hepatitis B Patient Testimony for trial: Trial Name: NCT05867056 — Phase 1
~35 spots leftby Oct 2025