Clinical Research Directory
Browse clinical research sites, groups, and studies.
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy. If the patient has an allergy, the body's defense system (immune system) overreacts to an allergen (eg, certain foods like peanuts, milk, shellfish) by making antibodies called IgE. An antibody is a protein that allows the immune system to find and fight off things the body does not recognize (allergens). IgE antibodies are sent out by cells like plasma cells. These antibodies and allergens bind to other cells that send out chemicals, causing an allergic reaction. The aim of the study is to see what side effects happen when linvoseltamab is combined with dupilumab. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * Does linvoseltamab combined with dupilumab affect other types of antibodies in the blood at different times * How much study drug(s) is in the blood at different times
Official title: A Phase 1 Dose-Escalation Study in Adults With Severe IgE-Mediated Food Allergy, to Assess the Safety, Tolerability, and Pharmacodynamic Effects of Short-Term Linvoseltamab Treatment, a BCMAxCD3 Bispecific Antibody to Induce T-Cell Killing of IgE Producing Plasma Cells, on Top of Chronic Dupilumab Treatment, to Prevent the Formation of New IgE Producing Plasma Cells
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2024-05-17
Completion Date
2028-03-28
Last Updated
2025-11-13
Healthy Volunteers
No
Conditions
Interventions
linvoseltamab
Administered by intravenous (IV) infusion
dupilumab
Administered by subcutaneous (SC) injection
Locations (7)
University of South Florida
Tampa, Florida, United States
Emory University- Winship Cancer Institute
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Clinica Universidad de Navarra - Madrid
Madrid, Spain
Clinica Universidad de Navarra- Pamplona
Pamplona, Spain