What side effects are associated with this type of intervention?

Common treatments for Chronic Hepatitis B, such as tenofovir disoproxil fumarate (TDF) and lamivudine, are generally well-tolerated but can cause side effects like renal toxicity and bone mineral density loss for TDF, and potential development of drug resistance for lamivudine. Pegylated interferon, another treatment option, can lead to flu-like symptoms, depression, and hematologic abnormalities. Immune-modulating therapies, similar to the trial drug IMC-I109V, may also carry risks of immune-related adverse effects, though specific side effects for IMC-I109V are still under investigation.

What prior FDA approvals exist?

FDA-approved treatments for chronic hepatitis B include antiviral medications such as lamivudine, tenofovir alafenamide, and tenofovir disoproxil fumarate. These treatments primarily focus on inhibiting viral replication. While the context does not provide specific information on FDA-approved immune-mobilizing monoclonal T cell receptor (TCR) therapies like IMC-I109V, it does mention that lamivudine can restore T cell responsiveness in chronic hepatitis B patients, suggesting a potential immunomodulatory effect.

What other types of research exist?

Promising novel alternatives to IMC-I109V for Chronic Hepatitis B patients include pegylated interferon (PegIFN) combined with nucleos(t)ide analogues, next-generation HBV capsid assembly modulators (CAMs), and thymosin alpha 1.

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Monoclonal Antibodies

IMC-I109V for Chronic Hepatitis B

Phase 1

Waitlist Available

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after the last infusion of study treatment

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.

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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.