Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy (NCT06369467)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: University of South Florida — Tampa, Florida
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- University of South Florida — Tampa, Florida
- Emory University - Winship Cancer Institute — Atlanta, Georgia
- Massachusetts General Hospital — Boston, Massachusetts
- Icahn School of Medicine at Mount Sinai — New York, New York
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Food Allergy
- FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA — Coral Gables, Florida
- Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site — Palo Alto, California
- Natural History and Genetics of Food Allergy and Related Conditions — Bethesda, Maryland
- Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants — Stanford, California
- Effect of Omalizumab in the Skin of Food Allergy Patients — Denver, Colorado
Explore by condition: All Food Allergy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.