What is the mechanism of action of this treatment?

The most common treatments for Graft-versus-Host Disease (GVHD) include immunosuppressive therapies such as corticosteroids and monoclonal antibodies like Itolizumab. Itolizumab, an anti-CD6 monoclonal antibody, works by targeting the CD6 receptor on T-cells, thereby inhibiting their activation and proliferation. This is crucial for GVHD patients because it helps to reduce the immune-mediated damage to the recipient's tissues, improving clinical outcomes and reducing the severity of the disease. By modulating the immune response, these treatments aim to achieve a balance where the donor cells can engraft and function without causing excessive harm to the host.

What side effects are associated with this type of intervention?

Common treatments for Graft-versus-Host Disease (GVHD) include monoclonal antibodies like Itolizumab and corticosteroids. Monoclonal antibodies can cause infusion-related reactions, infections due to immunosuppression, and potential liver enzyme abnormalities. Corticosteroids, often used in combination, can lead to side effects such as hyperglycemia, hypertension, increased risk of infections, osteoporosis, and gastrointestinal issues. Both treatments aim to modulate the immune response but come with a risk of significant adverse effects that require careful monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Graft-versus-Host Disease (GVHD), including monoclonal antibodies and immunosuppressive agents. Notable approvals include ruxolitinib (Jakafi), a JAK1/2 inhibitor, and tocilizumab (Actemra), an IL-6 receptor antagonist. Additionally, corticosteroids like prednisone are frequently used as first-line therapy. While Itolizumab, an anti-CD6 monoclonal antibody, is currently being studied, other monoclonal antibodies such as abatacept (Orencia), which targets CTLA-4, have also been explored for GVHD treatment.

What other types of research exist?

Promising novel alternatives to Itolizumab for GVHD patients include: 1) Ruxolitinib, a JAK1/2 inhibitor, which has shown efficacy in steroid-refractory acute GVHD. 2) Abatacept, a CTLA-4 Ig fusion protein, which has demonstrated potential in preventing acute GVHD. 3) Vedolizumab, an anti-integrin antibody, which is being explored for its role in treating steroid-refractory GVHD. These therapies are supported by recent clinical trials and are expected to be relevant treatment options in 2024.

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Corticosteroid

Itolizumab + Corticosteroids for Acute Graft-Versus-Host Disease

Phase 3

Recruiting

Research Sponsored by Equillium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.

Is age ≥12 years and >40kg at informed consent/assent.

Must not have

Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.

An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 99

Awards & highlights

Pivotal Trial

Summary

This trial is testing itolizumab, an IV medication, in patients with severe aGVHD. It aims to see if itolizumab can better control the immune system and reduce inflammation. Itolizumab has been used in various conditions including psoriasis, rheumatoid arthritis, and COVID-19.

Who is the study for?

This trial is for individuals over 12 years old and heavier than 40kg who have had a bone marrow transplant and are now facing a severe reaction called acute Graft Versus Host Disease (aGVHD). They should have started steroid treatment within the past 72 hours. People with chronic GVHD, other ongoing treatments for aGVHD besides steroids, or those with certain types of cancer relapse or persistent disease aren't eligible.

What is being tested?

The study is testing Itolizumab in combination with corticosteroids against a placebo plus corticosteroids to see which is better as an initial treatment for severe forms of aGVHD following bone marrow transplantation.

What are the potential side effects?

Itolizumab may cause immune system reactions, infections due to lowered immunity, infusion-related reactions similar to allergic responses, and potential impact on liver function. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stem cell transplant from a donor.

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I am 12 years or older and weigh more than 40kg.

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I have a severe form of acute graft-versus-host disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking immunosuppressants other than corticosteroids for aGVHD.

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I had an emergency cell transplant due to cancer returning after a stem cell transplant.

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I need treatment for remaining disease not specified before my stem cell transplant.

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I have chronic graft-versus-host disease or overlap syndrome.

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I haven't taken high doses of steroids for conditions other than aGVHD in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 99

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 99

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 99 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.

Secondary study objectives

Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures

Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Itolizumab (EQ001)Experimental Treatment1 Intervention

Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.

Group II: EQ001 PlaceboPlacebo Group1 Intervention

EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses

0 / 8Eligibility criteria met

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 Graft-versus-Host Disease (GVHD) include immunosuppressive therapies such as corticosteroids and monoclonal antibodies like Itolizumab. Itolizumab, an anti-CD6 monoclonal antibody, works by targeting the CD6 receptor on T-cells, thereby inhibiting their activation and proliferation. This is crucial for GVHD patients because it helps to reduce the immune-mediated damage to the recipient's tissues, improving clinical outcomes and reducing the severity of the disease. By modulating the immune response, these treatments aim to achieve a balance where the donor cells can engraft and function without causing excessive harm to the host.