Sublingual Immunotherapy for Nut Allergies

(CASCADES Trial)

Overseen By Edwin H Kim, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Monoclonal antibodies

Disqualifiers: Severe asthma, Anaphylaxis, Eosinophilic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for children with cashew allergies using sublingual immunotherapy (SLIT), which involves placing a small amount of cashew extract under the tongue. The main goal is to determine if this method is safe and effective in reducing allergic reactions over time. A placebo group is included for comparison. Children aged 1-11 years with known cashew allergies and allergic reactions to cashews may be suitable candidates for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking antihistamines at least 5 days before certain tests. If you're on certain asthma medications or other allergy treatments, you might need to stop those too. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that cashew sublingual immunotherapy is likely to be safe for children?

Research has shown that sublingual immunotherapy (SLIT) for food allergies is generally safe. Most safety data comes from studies on peanut and cow's milk SLIT, with encouraging results for other nuts like cashews. In these studies, SLIT was well-tolerated, with most participants not experiencing serious side effects.

For cashew SLIT specifically, information remains limited. However, since peanut SLIT has proven safe, experts believe cashew SLIT might have similar safety. Mild reactions like an itchy mouth or throat may occur, but serious problems are unlikely.

As this trial is in an early stage, researchers continue to gather detailed safety information for cashew SLIT. Existing evidence from similar treatments suggests it may be safe for most participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for nut allergies that rely on oral immunotherapy or injectable medications, the Cashew Sublingual Immunotherapy (SLIT) offers a unique delivery method by using a glycerinated cashew extract administered under the tongue. This approach can potentially make the treatment more convenient and less invasive than traditional methods. Researchers are excited because this sublingual method aims to desensitize the immune system gradually, potentially reducing allergic reactions to cashews with fewer side effects and discomfort.

What evidence suggests that Cashew Sublingual Immunotherapy might be an effective treatment for cashew allergy?

Research has shown that sublingual immunotherapy (SLIT), which involves placing a small amount of allergen under the tongue, effectively treats various food allergies, such as peanuts and tree nuts. Studies have found that SLIT can safely reduce allergic reactions by gradually training the immune system to be less sensitive. This trial will specifically test Cashew SLIT, using glycerinated cashew extract, to evaluate its effectiveness in reducing allergic reactions to cashews. Early results from similar techniques suggest that SLIT could help with cashew allergies, offering hope to children with this specific allergy. Overall, SLIT has a history of reducing allergy symptoms and improving tolerance in patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Edwin H Kim, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for children aged 1-11 with a cashew allergy. The full eligibility criteria are not provided, but typically participants must have a confirmed diagnosis and be in good health aside from their allergy.

Inclusion Criteria

Cashew allergy with defined criteria

Positive Double-Blind Placebo Controlled Food Challenge (DBCPFC) to 443 mg cumulative cashew at enrollment

I am between 1 and 11 years old.

Exclusion Criteria

History of severe anaphylaxis to cashew

Participation in any interventional study within the past 3 months

Inability or unwillingness to give written informed consent and/or comply with the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Buildup

Participants undergo a 5-month dose buildup period of cashew SLIT or placebo

5 months

Visits at baseline, months 1, 3, and 6

Maintenance Treatment

Participants continue with 12 months of maintenance cashew SLIT or placebo

12 months

Visits at months 6, 12, and 18

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cashew Sublingual Immunotherapy

Trial Overview The CASCADES study is testing the safety and effectiveness of cashew sublingual immunotherapy (SLIT) compared to a placebo. Children will receive treatment under their tongue to see if it can reduce their allergic reactions over an 18-month period.

How Is the Trial Designed?

Group I: Cashew SLIT Active Control 1 Intervention

Glycerinated cashew extract for sublingual immunotherapy

Group II: Placebo control Placebo Group 1 Intervention

Glycerinated for placebo sublingual immunotherapy

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Food Allergy Research & Education

Collaborator

Trials

6

Recruited

31,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07170540

NCT07170540 | UNC Cashew Sublingual Immunotherapy Cashew Nut AllergyTree Nut Allergies. Cashew Nut AllergyTree Nut Allergies ... Food immunotherapy such as Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250214/

Sublingual immunotherapy as an option for effective food ... In clinical practice, this approach has been used for a wide variety of food allergens, including peanut, tree nuts, milk, egg, soy, wheat, seafood, and legumes ...

3. news.unchealthcare.org news.unchealthcare.org/2024/11/kim-receives-1-million-grant-for-novel-multi-nut-allergy-treatment-study/

Kim Receives $1-Million Grant for Novel Multi-nut Allergy ... The safety seen with SLIT for peanut allergy, commonly recognized as one of the most severe allergies, makes it ideal for multiple tree nut ...

4. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(24)00198-3/fulltext

Safety and Effectiveness of Bypassing Oral Immunotherapy ... Figure E1 The entire food SLIT journey at BC Children's Hospital. Dose no. Protein (mg), Amount (g) of peanut powder for mixture ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1081120625001164

The use of grocery-sourced real-food solutions in ... Sublingual immunotherapy (SLIT) is a treatment that has been safely and effectively used to desensitize patients to food allergens, including peanut, cow's milk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12215136/

Efficacy of cashew nut protein immunotherapy - PubMed Central Cashew is one of the three most allergenic tree nuts in Europe and the most common cause of tree nut allergy in Australia. In Poland, cashew ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213219824001983

Safety and Effectiveness of Bypassing Oral Immunotherapy ... Because of its favorable safety, sublingual immunotherapy (SLIT) for food allergy ... Most clinical trial safety data describe peanut or cow's milk SLIT ...