A Phase 1 Study of Cizutamig in IgE Mediated Diseases

NCT07408869 | Not Yet Recruiting Phase 1

• 1 other identifier: CND106-110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.

Conditions

IgE-Mediated Hypersensitivity; IgE Mediated Food Allergy; IgE-Mediated Cow Milk Allergy

Keywords

peanut allergy; nut allergy; hazelnut allergy; walnut allergy; cashew allergy; milk allergy; egg allergy; soy allergy; wheat allergy; sesame allergy; cod allergy; salmon allergy; tuna allergy; lobster allergy; crab allergy; shrimp allergy; food allergy; rhinosinusitis; allergic rhinitis; asthma; urticaria; atopic dermatitis; immune system; cizutamig; T cell engager

Outcome Measures

Primary Outcomes (1)

• To evaluate the ability of cizutamig to reduce IgE levels

  Change from baseline in serum IgE

  Baseline to Week 12

Secondary Outcomes (26)

• Incidence and severity of treatment-emergent adverse events through end of study

  Baseline to Week 24

• PK parameters: Cmax

  Baseline to 24 Weeks

• PK parameters: Tmax

  Baseline to Week 24

• PK parameters: AUC

  Baseline to 24 Weeks

• PK Parameter: CL

  Baseline to 24 Weeks

Study Arms (2)

cizutamig (single dose)

EXPERIMENTAL

cizutamig will be dosed subcutaneously according to the cohort assignment

Biological: Cizutamig

cizutamig (multiple dose)

EXPERIMENTAL

cizutamig will be dosed subcutaneously according to the cohort assignment

Biological: Cizutamig

Interventions

Cizutamig BIOLOGICAL

cizutamig will be dosed SC according to the assigned cohort

cizutamig (multiple dose); cizutamig (single dose)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient meets at least one of the following:
• History of documented (skin prick test, in vitro testing, or food challenge), ongoing, IgE-mediated allergy to food (eg, peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp) with Screening total IgE ≥ 400 IU/mL
• Diagnosis of chronic rhinosinusitis with Screening total IgE \> ULN
• Diagnosis of allergic rhinitis with Screening total IgE \> ULN
• Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE \> ULN
• Diagnosis of chronic spontaneous urticaria with symptoms (eg, wheals or angioedema) for at least 6 weeks any time prior to screening and Screening total IgE \> ULN
• Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE \> ULN
• Agree to the use of highly effective contraception

You may not qualify if:

• Elevated IgE levels for reasons other than the IgE mediated diseases
• Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)
• Current use of any allergen immunotherapy.
• Individuals whose allergen exposures in their home and/or work environments may be expected to change significantly during the trial period
• Inadequate clinical laboratory parameters at Screening
• Receipt of or inability to discontinue any excluded therapies
• Individuals who will decline blood products
• Active infection
• Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF
• Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)
• History of primary immunodeficiency
• History of CNS disease
• History of poorly controlled diabetes, chronic kidney disease, chronic pulmonary disease, uncontrolled cardiovascular disease, history of malignancy within 5 years
• History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug
• Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period

Sponsors & Collaborators

• Candid Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Food Hypersensitivity; Peanut Hypersensitivity; Nut Hypersensitivity; Milk Hypersensitivity; Egg Hypersensitivity; Wheat Hypersensitivity; Rhinosinusitis; Rhinitis, Allergic; Asthma; Urticaria; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity; Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous

Central Study Contacts

Clinical Operations

CONTACT

+1 858-247-0550; ClinicalTrials@candidrx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

AU (1)