A Clinical Study of Cizutamig in Thyroid Eye Disease (NCT07597200) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study of Cizutamig in Thyroid Eye Disease
China38 participantsStarted 2026-05-08
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of treatment-emergent adverse events through end of study
Timeframe: Baseline to Month 12
2
Changes from baseline in vital signs through end of study: body temperature
Timeframe: Baseline to Month 12
3
Changes from baseline in vital signs through end of study: heart rate
Timeframe: Baseline to Month 12
4
Changes from baseline in vital signs through end of study: respiratory rate
Timeframe: Baseline to Month 12
5
Changes from baseline in vital signs through end of study: blood pressure
Timeframe: Baseline to Month 12
6
Changes from baseline in vital signs through end of study: pulse oximetry
Timeframe: Baseline to Month 12
7
Changes from baseline in ECG parameters through end of study: PR interval