Clinical Trials in China / NCT07597200
Recruiting
Phase 1
A Clinical Study of Cizutamig in Thyroid Eye Disease
NCT07597200 · tracked via the Priya Life Science China tracker
Condition(s) studied
Thyroid Eye Disease, TED
Investigational drug(s) / intervention(s)
Cizutamig will be dosed according to the protocol.
Cizutamig will be dosed according to the protocol.: CND106
Study 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
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
Primary outcome measure(s)
- Incidence and severity of treatment-emergent adverse events through end of study — Baseline to Month 12
- Changes from baseline in vital signs through end of study: body temperature — Baseline to Month 12
- Changes from baseline in vital signs through end of study: heart rate — Baseline to Month 12
- Changes from baseline in vital signs through end of study: respiratory rate — Baseline to Month 12
- Changes from baseline in vital signs through end of study: blood pressure — Baseline to Month 12
- Changes from baseline in vital signs through end of study: pulse oximetry — Baseline to Month 12
- Changes from baseline in ECG parameters through end of study: PR interval — Baseline to Month 12
- Changes from baseline in ECG parameters through end of study: QRS interval — Baseline to Month 12
- Changes from baseline in ECG parameters through end of study: QTcF interval — Baseline to Month 12
- Changes from baseline in safety laboratory assessments through end of study: serum chemistry — Baseline to Month 12
- Changes from baseline in safety laboratory assessments through end of study: hematology — Baseline to Month 12
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | Recruiting |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Recruiting |
| The Eighth Affiliated Hospital of Southern Medical University (Shunde District People's Hospital of Foshan City) | Foshan | Guangdong | Recruiting |
| Guangdong Provincial People's hospital | Guangzhou | Guangdong | Recruiting |
| Xiangya Hospital of Central South University | Changsha | Hubei | Recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Recruiting |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | Recruiting |
| The First Affiliated Hospital of China Medical University | Shenyang | Liaoning | Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines | Shanghai | Shanghai Municipality | Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07597200 on ClinicalTrials.gov ↗ ← All trials in China