A Phase 1 Study of Cizutamig in IgE Mediated Diseases

Korábbi kezelés

• Current use of any allergen immunotherapy.
• Receipt of or inability to discontinue any excluded therapies
• Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period
• Blood donation or significant blood loss within 30 days prior to screening

Más betegség

• 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)
• Active infection
• Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF
• 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
• A history of severe allergic or anaphylactic reactions related to the underlying IgE mediated disease

Laborértékek

• Inadequate clinical laboratory parameters at Screening

Egyéb

• Individuals whose allergen exposures in their home and/or work environments may be expected to change significantly during the trial period
• Individuals who will decline blood products
• Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)
• Individuals considered to be part of a vulnerable population (eg, incarceration)
• Individuals that in the opinion of the Investigator, are not suitable for participation in the trial
• Inability to comply with protocol-mandated requirements

• 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