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RecruitingNCT07447869LYNXUpdated May 1, 2026

LYmph Node eXamination in Cat Allergen Immunotherapy

An Early Phase 1 interventional study of Intradermal cat allergen challenge in Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Sixteen eligible cat-allergic participants will be accrued in the study. Eight participants who have been on subcutaneous immunotherapy (SCIT) at maintenance dosing for at least 1 year will be assigned to the SCIT cohort, and 8 participants who have never been on cat immunotherapy will be assigned to the No immunotherapy (IT) cohort. Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1), will undergo axillary lymph node and peripheral blood sampling at Day 4, and axillary lymph node, peripheral blood, and adenoid and nasal sampling at Week 3.

The primary objective is to determine the number of analyzable cells from axillary lymph node fine-needle aspiration 3 days and 3 weeks after intradermal cat allergen challenge in two cohorts of cat-allergic participants: those undergoing cat allergen immunotherapy and those who are not receiving this treatment

02

Conditions studied

  • Allergy

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Keywords

  • cat allergen
  • subcutaneous immunotherapy
  • immunotherapy
03

In context

Hypersensitivity

1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.

This study's planned enrollment of 16 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant must be able to understand and provide
  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 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

Exclusion Criteria:

  1. Inability or unwillingness of a participant to give written 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
  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 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 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 product within the past 4 months or 5 half-lives (whichever is longer) prior to screening
    3. Receipt of systemic 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 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. >= 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
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    No immunotherapy (IT) Cohort

    Participants who have never been on cat immunotherapy will be assigned to this cohort Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1), will undergo axillary lymph node and peripheral blood sampling at Day 4, and axillary lymph node, peripheral blood, and adenoid and nasal sampling at Week 3. Lymph node sampling will occur in one axilla at Day 4 and in the contralateral axilla at Week 3

    Drug: Intradermal cat allergen challenge

  • Experimental
    Subcutaneous Immunotherapy (SCIT) cohort

    Participants who have been on Subcutaneous Immunotherapy (SCIT) at maintenance dosing for at least 1 year will be assigned to this cohort. Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1), will undergo axillary lymph node and peripheral blood sampling at Day 4, and axillary lymph node, peripheral blood, and adenoid and nasal sampling at Week 3. Lymph node sampling will occur in one axilla at Day 4 and in the contralateral axilla at Week 3

    Drug: Intradermal cat allergen challenge

Interventions

  • DrugIntradermal cat allergen challenge

    Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1)

06

What researchers measure

Primary outcomes

  1. Total number of analyzable cells from the lymph node fine-needle aspiration

    The total number of analyzable cells per Fine-Needle Aspiration (FNA) sample will be summarized descriptively (Mean and Standard Deviation, Median, Minimum, and Maximum values, and proportion of samples yielding \>100,000 analyzable cells)

    Time frame: At Day 4 and Week 3

Secondary outcomes

  1. Total number of adverse events related to lymph node sampling

    Adverse Events (AEs) assessed as related to the lymph node sampling will be summarized by cohort and overall

    Time frame: From Baseline to Week 3

  2. Total number of adverse events related to adenoid swab

    The summarization of adverse events (AEs) related to lymph node sampling will be repeated for the AEs assessed as related to the adenoid swab

    Time frame: From Baseline to Week 3

07

Study locations

1 of 1 sites recruiting
  • Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
    Boston, Massachusetts 02215, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07447869
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Apr 10, 2026
Primary completion
Jan 27, 2027 (estimated)
Completion
Jan 27, 2027 (estimated)
Last update
May 1, 2026

Study contacts

Tanya M Laidlaw, MD
Contact
tlaidlaw@bwh.harvard.edu
617-732-9850
Carolyn Baloh, M.D.
principal investigator · Brigham and Women's Hospital: Division of Allergy and Clinical Immunology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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