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Experimental cocktail aims to silence Life-Threatening food allergies

NCT ID NCT06369467

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests two drugs together—linvoseltamab and dupilumab—in just 6 adults with severe food allergies. The goal is to see if the combination is safe and can lower IgE antibodies that trigger allergic reactions. Participants must have a history of anaphylaxis to foods like peanuts, milk, or shellfish. The trial focuses on safety and side effects, not yet on curing the allergy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linvoseltamab and dupilumab
What this could lead to
If it works, this could point toward a way to reduce or eliminate severe allergic reactions to foods like peanuts, milk, and shellfish.
What could go wrong
This is a very early, tiny Phase 1 trial with only 6 people. It is primarily checking safety, not effectiveness. The combination may cause side effects or fail to reduce allergies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

May 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Clinical history of documented, ongoing, severe IgE-mediated allergy to food (peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp; documented symptom\[s\] of anaphylaxis due to exposure) 2. History of physician reported anaphylaxis to food requiring epinephrine administration and/or requiring an emergency visit or inpatient hospitalization 3. Participants with dupilumab-indicated atopic dermatitis (AD) must be receiving DUPIXENT as standard of care for the treatment of AD for a minimum of 12 weeks prior to screening OR Participants with dupilumab-indicated eosinophilic esophagitis (EoE) must be receiving DUPIXENT as standard of care for the treatment of EoE for a minimum of 12 weeks prior to screening OR Must be willing to initiate dupilumab treatment for food allergy 4. Participants initiating dupilumab treatment must agree to remain on dupilumab for the duration of the combination study treatment and safety follow-up periods. Participants who elect to enter the linvoseltamab re-dosing period, must also remain on continuous dupilumab treatment as outlined. Participants on commercial DUPIXENT must agree to remain on their prescribed dose, as described in the protocol, for the duration of the combination study treatment period 5. Participant must be willing to use an epinephrine auto-injector device 6. Participant must be willing to receive booster and/or re-vaccination(s), including for live (attenuated) vaccinations, based on results of vaccine antibody titers and investigator opinion 7. Has a body mass index between 18 and 32 kilogram per square metre (kg/m2), inclusive Key Exclusion Criteria: 1. Pregnant or breastfeeding women 2. History of chronic disease (other than AD or EoE) requiring therapy (eg, heart disease, diabetes, hypertension) that, in the opinion of the principal investigator, would represent a risk to the participant's health or safety in this study or the participant's ability to comply with the study protocol. Participants on DUPIXENT for conditions other than AD or EoE (eg, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, etc) are excluded 3. Known or suspected progressive multifocal leukoencephalopathy (PML), or history of PML, neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure within 12 months prior to Day 1 4. Recent history (within past 30 days) of a grade 3 or grade 4 gastrointestinal bleed, history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation 5. History of moderate or severe asthma based on the Global Initiative for Asthma (GINA) guidelines 6. Pre-bronchodilator forced expiratory volume in the first second (FEV1) \<80% of predicted using local reference values 7. Any prior exposure to a B-cell maturation antigen (BCMA) targeted therapy 8. Use of systemic corticosteroids within 2 months prior to screening 9. Use of other forms of allergen immunotherapy (eg, oral, SC, patch, or sublingual) or immunomodulatory therapy (not including corticosteroids) within 4 months prior to screening 10. Unwilling to discontinue use of antihistamines within 5 days prior to screening and within 5 days prior to skin prick test (SPT) 11. Hypersensitivity to epinephrine and any of the excipients in the epinephrine product 12. Within the previous 2 months of the screening visit has a history of bacterial, protozoal, viral or parasite infection requiring hospitalization or treatment with IV anti-infectives 13. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit NOTE: Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida

    Tampa, Florida, 33613, United States

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