Intralymphatic cat-allergy immunotherapy for people with cat-induced rhinitis and asthma

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

This trial tests whether three to four ultrasound-guided injections of a cat-allergy vaccine into an inguinal lymph node are safe and trigger helpful immune responses in adults with cat-caused allergic rhinitis, with or without asthma.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Zurich (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Zurich)
• Trial ID: NCT06960382 on ClinicalTrials.gov

What this trial studies

This phase 1/2 interventional study administers 3–4 intralymphatic injections of ALUTARD SQ Felis domesticus into an ultrasound-guided inguinal lymph node using much lower doses than standard subcutaneous immunotherapy. Participants are monitored for systemic allergic reactions following WAO guidelines, have serum tryptase measured, and undergo lung function tests and symptom questionnaires to evaluate asthma effects. Immunogenicity is measured by ImmunoCAP and basophil activation testing (CAST ELISA), and a modified nasal provocation test is used to gauge treatment effect. Results will be compared to conventional subcutaneous immunotherapy data to characterize safety, tolerability, and immune responses and to inform later efficacy trials.

Who should consider this trial

Good fit: Adults with confirmed cat-dander–induced allergic rhinitis, with or without controlled mild-to-moderate asthma (FEV1 ≥ 70% predicted), who can attend in-person visits and give informed consent.

Not a fit: People with uncontrolled or severe asthma, a recent severe asthma exacerbation, chronic obstructive or restrictive lung disease, immune deficiency or active autoimmune disease, hypersensitivity to phenol, or active malignancy are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, ILIT could offer effective cat-allergy immunotherapy with far fewer injections, lower allergen doses, and a lower risk of systemic reactions than conventional subcutaneous treatment.

How similar studies have performed: Small prior ILIT studies for pollen and some other allergens have shown promising safety and immune-response signals, but ILIT for cat allergen is relatively novel and not yet proven in large trials.

Eligibility criteria

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 wish to become pregnant or do not use contraception.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.

Where this trial is running

Zurich

• University Hospital Zurich — Zurich, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Pål Johansen, Professor, PhD

Conditions: Allergic Rhinitis, Allergic Asthma, cat allergy, asthma, rhinitis, immunotherapy, intralymphatic injection, ILIT