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).

Study Overview

• Status: Recruiting
• Conditions: Thyroid Eye Disease, TED
• Intervention / Treatment: Drug: Cizutamig will be dosed according to the protocol.

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Martin Zhuang; Phone Number: +86 13918519658; Email: martin@candidrx.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Recruiting
      • Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines
      • Contact: Huifang Zhou, Ph.D; Phone Number: +86 13661901886; Email: fangzzfang@sjtu.edu.cn
      • Contact: Lina Xing, Ph.D; Phone Number: +86 13918035850; Email: jygcp666@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cizutamig	Drug: Cizutamig will be dosed according to the protocol.; CND106

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of treatment-emergent adverse events through end of study	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 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 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

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameters for Cizutamig: time of maximum concentration	Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve	Baseline to Month 12
PK parameters for Cizutamig: clearance	Baseline to Month 12
PK parameters for Cizutamig: volume of distribution	Baseline to Month 12
PK parameters for Cizutamig: half-life	Baseline to Month 12
Pharmacokinetic (PK) parameters for Cizutamig: Cmax	Baseline to Month 12

Collaborators and Investigators

• Sponsor: Candid Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Graves Ophthalmopathy
• Other Study ID Numbers: CND106-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No