Actively Recruiting
LYNX: LYmph Node eXamination in Cat Allergen Immunotherapy (ITN102AD)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-01
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the immune system responds to cat allergens in people with cat allergies, focusing on those who are receiving cat allergen immunotherapy and those who are not. This early phase 1 trial aims to understand the number of immune cells in lymph nodes after a controlled exposure to cat allergen, which may help improve allergy treatments in the future. The study has two groups: one group of participants who have been receiving subcutaneous immunotherapy (SCIT) for at least one year, and another group who have never had cat immunotherapy. Both groups will receive an intradermal cat allergen challenge on both upper arms on Day 1. Participants will have lymph node and blood samples taken on Day 4 and again at Week 3. Additional samples from adenoid and nasal areas will also be collected at Week 3. Lymph node sampling alternates between axillary sites at these time points. Participants will be involved in several visits over three weeks, including allergen challenges, fine-needle aspirations of lymph nodes, blood draws, and nasal and adenoid sample collections. Researchers will measure the total number of analyzable cells from lymph node samples taken at Day 4 and Week 3. They will also monitor any adverse events related to lymph node sampling and adenoid swabs throughout the study. The study will last from baseline through Week 3, with safety follow-up included during this period.
CONDITIONS
Brief Title
LYmph Node eXamination in Cat Allergen Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be able to understand and provide informed consent
- Clinical history of moderate to severe rhinoconjunctivitis symptoms caused by cat exposure interfering with daily activities or sleep
- Skin prick test wheal ≥ 5 mm to standardized cat extract or cat-specific IgE ≥ 0.7 kU/L within 5 years
- Female participants of childbearing potential must have a negative pregnancy test at screening
- For SCIT cohort: at least 1 year of maintenance subcutaneous allergen immunotherapy to cat, with ongoing treatments at least every 6 weeks
You will not qualify if you...
- Inability or unwillingness to give written informed consent or comply with protocol
- Current household or regular occupational exposure to cats
- For No immunotherapy cohort: any previous or current immunotherapy treatment with cat allergen
- History of grade 4 anaphylaxis by WAO criteria
- Partially controlled or uncontrolled asthma in last 4 weeks; severe asthma or asthma hospitalization in last 12 months
- History of chronic obstructive pulmonary disease
- Recurrent acute sinusitis requiring antibiotics or chronic sinusitis with major/minor factors
- Immune system diseases, including autoimmune disease or immunodeficiency
- History of malignancy except certain skin or cervical cancers treated at least 12 months prior
- Tobacco, vaping, or illicit inhaled substances within 6 weeks
- Recent investigational product, corticosteroid, immunoglobulin, blood product, immunosuppressant, biologic, or vaccination use within defined timeframes
- Pregnant, planning pregnancy, or breastfeeding
- Bleeding disorders
- BMI ≥ 40
- Anatomic or musculoskeletal issues interfering with lymph node sampling
- History of lymphedema
- Other medical conditions posing risks or interfering with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants undergo intradermal cat allergen challenge and lymph node, peripheral blood, adenoid, and nasal sampling to evaluate their immune response.
3 visits: baseline (Day 1), Day 4, and Week 3
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
T
Tanya M Laidlaw, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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