UNC Cashew Sublingual Immunotherapy

NCT07170540 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 24-2373G-202401-00621
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT. Lab studies and an oral food challenge after 6 months of cashew SLIT will help determine how quickly cashew SLIT begins to take effect.

Conditions

Cashew Nut Allergy; Tree Nut Allergies

Keywords

cashew allergy; tree nut allergy; food allergy; sublingual immunotherapy; SLIT

Outcome Measures

Primary Outcomes (1)

• Desensitization to cashew at month 18

  Percentage of participants tolerating \>/= 1043 mg during cashew DBPCFC at month 18

  18 months

Secondary Outcomes (7)

• Full desensitization to cashew at month 18

  18 months

• Desensitization to cashew at month 6

  6 months

• Adverse events related to study drug dosing

  18 months

• Change in cashew skin prick testing

  Baseline, Months 6 and 18

• Change in cashew Immunoglobulin E (IgE)

  Baseline, Months 6 and 18

Study Arms (2)

Cashew SLIT

ACTIVE COMPARATOR

Glycerinated cashew extract for sublingual immunotherapy

Drug: Cashew sublingual immunotherapy

Placebo control

PLACEBO COMPARATOR

Glycerinated for placebo sublingual immunotherapy

Drug: Placebo sublingual immunotherapy

Interventions

Cashew sublingual immunotherapy DRUG

Glycerinated cashew extract for use in sublingual immunotherapy

Cashew SLIT

Placebo sublingual immunotherapy DRUG

Glycerinated saline for placebo sublingual immunotherapy

Placebo control

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1-11 years at enrollment
• Cashew allergy, with allergy defined as:
• History of clinical reaction to cashew AND cashew-specific IgE \>/=0.35 kUA/L AND cashew SPT \>/=3 mm
• OR if no prior reaction, cashew-specific IgE \>/=5 kUA/L AND cashew SPT \>/=3 mm
• Positive Double-Blind Placebo Controlled Food Challenge (DBCPFC) to 443 mg cumulative cashew at enrollment
• If female of child-bearing potential, must have a negative urine or serum pregnancy test
• If female of childbearing potential (defined as females who have reached menarche or who are 12 years or older), must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy) during the treatment period

You may not qualify if:

• Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol
• History of severe anaphylaxis to cashew defined as neurological compromise or requiring intubation/mechanical ventilation
• Known oat, wheat, or glycerin allergy
• Poorly controlled or severe asthma/wheezing at screening, defined by at least one of the following criteria:
• Global Initiative for Asthma (GINA) 2024 criteria for uncontrolled asthma
• History of 2 or more systemic corticosteroid courses within 6 months of screening or one course of systemic corticosteroids within 3 months of screening to treat asthma/wheezing
• Prior intubation/mechanical ventilation for asthma/wheezing
• Hospitalization or overnight Emergency Department (ED) visit for asthma/wheezing within 6 months of screening
• Forced expiratory volume in one second (FEV1) \<80% of predicted or FEV1/forced vital capacity (FVC) \<75%, with or without controller medications (for participants \>/= 6 years and older, able to perform spirometry)
• Peak expiratory flow rate (PEFR) \<80% of predicted for participants \>6 and able to perform peak flow
• Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS)
• Eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease
• Inability to discontinue antihistamines at least 5 half-lives before scheduled SPT and DBPCFC
• Food immunotherapy such as Oral Immunotherapy (OIT), Sublingual Immunotherapy (SLIT), or Epicutaneous (EPIT) for cashew or pistachio within 6 months of enrollment
• Monoclonal antibodies such as omalizumab (Xolair), dupilumab (Dupixent), benralizumab (Fasenra), mepolizumab (Nucala), or other immunomodulatory therapy within 6 months of enrollment

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Food Allergy Research & Education: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Nut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Edwin H Kim, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwin H Kim, MD

CONTACT

919-537-3193; edwinkim@email.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)