RecruitingPhase 1NCT07597200
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
Sponsor
Candid Therapeutics
Enrollment
38 participants
Start Date
May 8, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria2
- -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 Criteria12
- 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
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Interventions
DRUGCizutamig will be dosed according to the protocol.
CND106
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07597200
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