Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Aller… (NCT06960382) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma
Switzerland36 participantsStarted 2025-08-20
Plain-language summary
The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhinitis and asthma. The main questions it aims to answer are:
Is ILIT with ALUTARD SQ Felis domesticus safe and well tolerated?
What immunological responses play a role in ILIT?
Researchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy.
Participants will:
Receive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound.
Undergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement.
Complete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy.
Provide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA.
Inclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma.
Exclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 \< 70%), recent severe asthma exacerbations, or serious comorbidities.
The study aims to generate data to inform future efficacy trials.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed consent as documented by signature.
* Cat-dander-induced ARC as confirmed by patient history and type-1-sensitization to cat dander in skin and/or serum.
Exclusion Criteria:
* Hypersensitivity to phenol.
* Planned depot steroid injection for treatment of ARC
* Patients with uncontrolled asthma or FEV1 \< 70% of the predicted value in adults (after adequate pharmacological therapy).
* Patients with a severe asthma exacerbation in the past 3 months.
* Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).
* Chronic obstructive or restrictive lung disease.
* Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.
* Severe chronic inflammatory diseases.
* Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment visit.
* Chronic obstructive or restrictive lung disease
* Patients with malignant tumours that currently have clinical significance.
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).
* Known cardiovascular disease, i.e., not even NYHA class I.
* Use of ACE-blockers.
* Recent or on-going hepatic or renal disease.
* Severe chronic renal insufficiency (due to aluminium burden).
* Alcohol or drug abuse
* Women who are pregnant and breast feeding
* Women of childbearing age who …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of blood tryptase levels at baseline, after first ILIT and in case of systemic allergic reactions
Timeframe: From enrollment to the end of treatment at 8 monts. At Baseline, 2 hours after the first Injection and within 1 hour in case of systemic allergic reactions.
2
Incidence and severity of adverse events using the WAO rating system 2024
Timeframe: From enrollment to the end of treatment at 8 months.