A Clinical Study of Cizutamig in Thyroid Eye Disease

NCT07597200 · tracked via the Priya Life Science China tracker

Sponsor

Candid Therapeutics

Phase

Phase 1

Started

2026-05-08

Last updated

2026-09-01

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

More Candid Therapeutics trials in China

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG) Recruiting

Clinical Study of Cizutamig in Systemic Lupus Erythematosus Recruiting

Other trials for the same condition

Tofacitinib for Glucocorticoid-Resistant Moderate-to-Severe Thyroid Eye Disease Recruiting

Teprotumumab N01 Versus Methylprednisolone After Urgent Orbital Decompression for Dysthyroid Optic Neuropathy Starting soon

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