Lymph node examination during cat allergy immunotherapy

LYNX: LYmph Node eXamination in Cat Allergen Immunotherapy (ITN102AD)

This project will test how lymph nodes react after a small cat allergen skin challenge in people with cat allergy who are either on long-term allergy shots or have never had immunotherapy.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (nih)
• Drugs / interventions: Immunotherapy
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT07447869 on ClinicalTrials.gov

What this trial studies

Sixteen adults with clinical cat allergy will be enrolled into two cohorts of eight: one cohort on maintenance subcutaneous immunotherapy (SCIT) for at least one year and one cohort who have never received cat immunotherapy. Participants receive an intradermal cat allergen challenge at baseline, then undergo axillary lymph node fine-needle aspiration and peripheral blood sampling at Day 4 and again at Week 3, with additional adenoid and nasal sampling at Week 3. The primary objective is to determine the number of analyzable cells obtained from axillary lymph node aspirates at 3 days and 3 weeks after allergen challenge in the two cohorts. This is an early-phase interventional protocol focused on local immune responses in draining lymph nodes rather than clinical symptom outcomes.

Who should consider this trial

Good fit: Adults with moderate to severe rhinoconjunctivitis from cat exposure who have a skin prick wheal ≥5 mm or cat-specific IgE ≥0.7 kU/L, either on maintenance SCIT for at least one year or who have never had cat immunotherapy, are ideal candidates.

Not a fit: People without confirmed cat allergy, those who cannot undergo lymph node aspiration or intradermal allergen challenge, pregnant individuals, or those on conflicting immunomodulatory treatments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could improve understanding of how immunotherapy changes local lymph node immune responses and help design better or shorter immunotherapy approaches.

How similar studies have performed: Allergen skin challenges and lymph node or blood sampling have been used in small mechanistic studies before, but using axillary fine-needle aspirates after a cat intradermal challenge to compare long-term SCIT versus no immunotherapy is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Participant must be able to understand and provide informed consent
2. A clinical history of moderate to severe rhinoconjunctivitis symptoms caused by cat exposure, such that exposure is currently, or was historically to the initiation of treatment, interfering with usual daily activities or with sleep, as defined according to the ARIA classification of rhinitis
3. Skin prick test wheal greater than or equal to 5 mm to standardized cat extract or cat-specific IgE greater than or equal to 0.7 kU/L obtained within 5 years of screening. These can be obtained from medical records if available from the prior 5 years, or at the screening visit if not
4. Female participants of childbearing potential must have a negative pregnancy test at the screening visit prior to performing study procedures
5. For participants in the Subcutaneous Immunotherapy (SCIT) cohort, the following inclusion criterion applies as well: A history of at least 1 year of maintenance subcutaneous allergen immunotherapy to cat, with currently ongoing immunotherapy treatments at least every 6 weeks

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Current household exposure to cat or regular occupational exposure to cat
3. For participants in No immunotherapy (IT) cohort, any previous immunotherapy treatment with cat allergen
4. For participants in No IT cohort, any current treatment with any form of allergen immunotherapy
5. A history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria
6. Partially controlled or uncontrolled asthma as per Global Initiative for Asthma (GINA) guidelines in the 4 weeks prior to screening. Participants may be rescreened once asthma is well-controlled
7. Severe asthma as defined by GINA guidelines in the previous 12 months
8. History of emergency visit or hospital admission for asthma in the previous 12 months
9. History of chronic obstructive pulmonary disease
10. History of recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment
11. History of chronic sinusitis, defined as sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness
12. History of disease affecting the immune system such as autoimmune disease (e.g., systemic lupus erythematosus), immune complex disease (e.g., serum sickness), or immunodeficiency, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
13. History of malignancy of any type, excluding basal cell and squamous cell cancers of the skin that only required surgical excision or in situ carcinoma of the cervix study provided that curative therapy was completed at least 12 months prior to informed consent
14. Any of the following:

    1. Inhaled tobacco, vaping, or use of inhaled illicit substances within 6 weeks of screening
    2. Receipt of any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening
    3. Receipt of systemic corticosteroids within 14 days prior to screening
    4. Receipt of immunoglobulin within 5 months of screening
    5. Receipt of other blood product within 30 days of screening
    6. Use of an immunosuppressant or other immunomodulating drug, except for systemic corticosteroids, within 30 days prior to screening
    7. Use of biologics targeting the human immune system within the past 24 months prior to screening
    8. Receipt of any vaccination within the past 6 weeks prior to screening
15. Pregnant, planning a pregnancy during the study, or breast-feeding
16. Bleeding disorders
17. BMI \>= 40
18. Other anatomic or musculoskeletal abnormalities that would interfere with FNA sampling procedure
19. History of lymphedema
20. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital: Division of Allergy and Clinical Immunology — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Carolyn Baloh, M.D. — Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
• Study coordinator: Tanya M Laidlaw, MD

Conditions: Allergy, cat allergen, subcutaneous immunotherapy, immunotherapy