NCT06960382RecruitingPhase 1/2

Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma

Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 36 (estimated)
First submitted: 25 Mar 2025
Start date: 20 Aug 2025
Primary completion date: 31 May 2027
Lead sponsor: University of Zurich
Diseases: Asthma
NCT number: NCT06960382

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 36
From 20 Aug 2025 to the primary completion date, 31 May 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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).
Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment visit.
Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).
Alcohol or drug abuse
Participation in another study with investigational drug within the 30 days preceding and during the present study.

Other illness

Hypersensitivity to phenol.
Chronic obstructive or restrictive lung disease.
Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.
Severe chronic inflammatory diseases.
Chronic obstructive or restrictive lung disease
Patients with malignant tumours that currently have clinical significance.
Known cardiovascular disease, i.e., not even NYHA class I.
Recent or on-going hepatic or renal disease.
Severe chronic renal insufficiency (due to aluminium burden).
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Age

Women of childbearing age who wish to become pregnant or do not use contraception.

Other

Patients with a severe asthma exacerbation in the past 3 months.
Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).
Use of ACE-blockers.
Women who are pregnant and breast feeding

Who the study is looking for

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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University Hospital Zurich Coordinator of this site? Confirm its status	Zurich	Switzerland	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.