A Clinical Study of Cizutamig in Thyroid Eye Disease

A Phase 1b, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Clinical Activity of Cizutamig in Patients With Thyroid Eye Disease

The purpose of this study is to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).

This is a Phase 1b, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of cizutamig in patients with thyroid eye disease (TED).

Inclusion Criteria:

• 18-75 years old at the time of signing the Informed Consent Form
• Diagnosis of Graves' Disease with active, moderate to severe TED in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Thyroid-Associated Ophthalmology (2022) at Screening and Day 1

Exclusion Criteria:

• Inadequate clinical laboratory parameters at Screening
• Active infection present
• Receipt of, or inability to discontinue, any of the excluded therapies
• History of progressive multifocal leukoencephalopathy
• History of primary immunodeficiency
• Central nervous system disorders that the investigator considers would increase risk to the subject
• Investigator-determined significant comorbidity(ies)
• Have a diagnosis or history of malignant disease within 5 years prior to Screening
• Active tuberculosis or lack of documentation of completed treatment for active pulmonary tuberculosis
• History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig
• Pregnant or breastfeeding women
• Patients who do not agree to use highly effective contraception as specified in the protocol