Itolizumab + Corticosteroids for Acute Graft-Versus-Host Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not use immunosuppressants other than corticosteroids for treating aGVHD. You also need to be on a specific dose of corticosteroids when starting the trial.
Is the combination of Itolizumab and Corticosteroids safe for treating acute graft-versus-host disease?
Itolizumab, an anti-CD6 monoclonal antibody, has shown a good safety profile in studies for other conditions like rheumatoid arthritis and psoriasis, with no severe or serious adverse events reported. It has been used safely as a monotherapy in these conditions, suggesting it may be generally safe for human use.12345
What makes the drug Itolizumab unique for treating acute graft-versus-host disease?
Itolizumab is unique because it targets the CD6-ALCAM pathway, which plays a crucial role in T-cell activation and proliferation, making it a novel approach for controlling acute graft-versus-host disease. Unlike other treatments, itolizumab specifically inhibits T-cell activation without directly killing cells, offering a new mechanism to manage this condition.25678
What data supports the effectiveness of the drug Itolizumab in treating acute graft-versus-host disease?
Research shows that Itolizumab, an anti-CD6 monoclonal antibody, can inhibit T-cell activation and proliferation, which are key processes in acute graft-versus-host disease. It has also demonstrated favorable effects in autoimmune diseases like rheumatoid arthritis and psoriasis, suggesting its potential in modulating immune responses.23589
Who Is on the Research Team?
Chief Development Officer
Principal Investigator
Equillium, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive itolizumab or placebo in combination with corticosteroids, administered intravenously every 2 weeks for a total of 7 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Corticosteroids
- Itolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Equillium
Lead Sponsor
Biocon Limited
Industry Sponsor