NCT07597200

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
25mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2028

Study Start

First participant enrolled

May 8, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Thyroid Eye Disease, TED

Outcome Measures

Primary Outcomes (11)

  • 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

Secondary Outcomes (6)

  • Pharmacokinetic (PK) parameters for Cizutamig: Cmax

    Baseline to Month 12

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Cizutamig

EXPERIMENTAL
Drug: Cizutamig will be dosed according to the protocol.

Interventions

Cizutamig will be dosed according to the protocol.DRUG

CND106

Cizutamig

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Martin Zhuang

CONTACT

+86 13918519658martin@candidrx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

May 8, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)