AllergyEarly Phase 1LYNXNCT07447869
LYmph Node eXamination in Cat Allergen Immunotherapy
A Early Phase 1 study testing Intradermal cat allergen challenge in people with Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergy
- What is being tested?
- Intradermal cat allergen challenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 27 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participant must be able to understand and provide informed consent
- 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
- 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
- Female participants of childbearing potential must have a negative pregnancy test at the screening visit prior to performing study procedures
- 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
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Current household exposure to cat or regular occupational exposure to cat
- For participants in No immunotherapy (IT) cohort, any previous immunotherapy treatment with cat allergen
- For participants in No IT cohort, any current treatment with any form of allergen immunotherapy
- A history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria
- 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
Show all 28Show fewer
- Severe asthma as defined by GINA guidelines in the previous 12 months
- History of emergency visit or hospital admission for asthma in the previous 12 months
- History of chronic obstructive pulmonary disease
- History of recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment
- 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
- 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
- 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
- Any of the following:
- Inhaled tobacco, vaping, or use of inhaled illicit substances within 6 weeks of screening
- Receipt of any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening
- Receipt of systemic corticosteroids within 14 days prior to screening
- Receipt of immunoglobulin within 5 months of screening
- Receipt of other blood product within 30 days of screening
- Use of an immunosuppressant or other immunomodulating drug, except for systemic corticosteroids, within 30 days prior to screening
- Use of biologics targeting the human immune system within the past 24 months prior to screening
- Receipt of any vaccination within the past 6 weeks prior to screening
- Pregnant, planning a pregnancy during the study, or breast-feeding
- Bleeding disorders
- BMI >= 40
- Other anatomic or musculoskeletal abnormalities that would interfere with FNA sampling procedure
- History of lymphedema
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
Boston, Massachusetts, 02215
About this study
Official title: LYNX: LYmph Node eXamination in Cat Allergen Immunotherapy (ITN102AD)
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
- Conditions
- Allergy
- Being tested
- Intradermal cat allergen challenge
- Keywords
- cat allergen, subcutaneous immunotherapy, immunotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal cat allergen challengeDrug
Participants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1)
| Study group | Role | What they receive |
|---|---|---|
| No immunotherapy (IT) Cohort | Experimental | 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 Receives: Drug: Intradermal cat allergen challenge |
| Subcutaneous Immunotherapy (SCIT) cohort | Experimental | 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 Receives: Drug: Intradermal cat allergen challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At Day 4 and Week 3
Secondary outcomes (2)
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
Measured: From Baseline to Week 3
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
Measured: From Baseline to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start10 Apr 2026
- Primary completion27 Jan 2027 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carolyn Baloh, M.D., Principal investigator, Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447869
- Sponsor's protocol ID
- DAIT ITN102AD
- Acronym
- LYNX
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LYNX: LYmph Node eXamination in Cat Allergen Immunotherapy (ITN102AD)
- ClinicalTrials.gov ID
- NCT07447869
- Acronym / sponsor ID
- LYNX / DAIT ITN102AD
- Conditions
- Allergy
- Keywords
- cat allergen, subcutaneous immunotherapy, immunotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 27 Jan 2027 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No immunotherapy (IT) Cohort | Experimental | Drug: Intradermal cat allergen challengeParticipants 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 |
| Subcutaneous Immunotherapy (SCIT) cohort | Experimental | Drug: Intradermal cat allergen challengeParticipants 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be able to understand and provide informed consent
- 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
- 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
- Female participants of childbearing potential must have a negative pregnancy test at the screening visit prior to performing study procedures
- 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
Key exclusion criteria (28 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Current household exposure to cat or regular occupational exposure to cat
- For participants in No immunotherapy (IT) cohort, any previous immunotherapy treatment with cat allergen
- For participants in No IT cohort, any current treatment with any form of allergen immunotherapy
- A history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal cat allergen challengeParticipants will undergo intradermal cat allergen challenge in bilateral upper arms at baseline (Day 1) | Drug | No immunotherapy (IT) Cohort, Subcutaneous Immunotherapy (SCIT) cohort |
Primary outcome
Total number of analyzable cells from the lymph node fine-needle aspiration
Time frame: At Day 4 and Week 3
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)
2 secondary outcomes
Total number of adverse events related to lymph node sampling
Time frame: From Baseline to Week 3
Total number of adverse events related to adenoid swab
Time frame: From Baseline to Week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Division of Allergy, Immunology, and TransplantationLink provided by the sponsor.
- National Institute of Allergy and Infectious DiseasesLink provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolyn Baloh, M.D. principal investigator
Brigham and Women's Hospital: Division of Allergy and Clinical Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intradermal cat allergen challenge in people with Allergy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanya M Laidlaw, MD (617-732-9850, tlaidlaw@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of analyzable cells from the lymph node fine-needle aspiration (time frame: At Day 4 and Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.