Thyroid Eye Disease, TEDPhase 1NCT07597200
A Clinical Study of Cizutamig in Thyroid Eye Disease
A Phase 1 study testing Cizutamig will be dosed according to the protocol. in people with Thyroid Eye Disease, TED, run by Candid Therapeutics at 14 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Eye Disease, TED
- What is being tested?
- Cizutamig will be dosed according to the protocol.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 14 sitesChina
- Study dates
- 8 May 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hubei
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning
- Recruiting
The Eighth Affiliated Hospital of Southern Medical University (Shunde District People's Hospital of Foshan City)
Foshan, Guangdong
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
- Recruiting
Guangdong Provincial People's hospital
Guangzhou, Guangdong
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
- Recruiting
Shanghai Ninth People's hospital Shanghai Jiaotong University school of medicines
Shanghai, Shanghai Municipality
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: 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).
Read the 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).
- Conditions
- Thyroid Eye Disease, TED
- Being tested
- Cizutamig will be dosed according to the protocol.
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cizutamig will be dosed according to the protocol.Drug
CND106
| Study group | Role | What they receive |
|---|---|---|
| Cizutamig | Experimental | Not described Receives: Drug: Cizutamig will be dosed according to the protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events through end of study
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Measured: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
Measured: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Measured: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Measured: Baseline to Month 12
Secondary outcomes (6)
Pharmacokinetic (PK) parameters for Cizutamig: Cmax
Measured: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Measured: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Measured: Baseline to Month 12
PK parameters for Cizutamig: clearance
Measured: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Measured: Baseline to Month 12
PK parameters for Cizutamig: half-life
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start8 May 2026
- Primary completion31 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye Disease, TEDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597200
- Sponsor's protocol ID
- CND106-109
- Status last verified
- Aug 2026
- First submitted
- 13 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07597200
- Acronym / sponsor ID
- CND106-109
- Conditions
- Thyroid Eye Disease, TED
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Candid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cizutamig | Experimental | Drug: Cizutamig will be dosed according to the protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cizutamig will be dosed according to the protocol.CND106 | Drug | Cizutamig |
Primary outcome
Incidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
Time frame: Baseline to Month 12
6 secondary outcomes
Pharmacokinetic (PK) parameters for Cizutamig: Cmax
Time frame: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Time frame: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Time frame: Baseline to Month 12
PK parameters for Cizutamig: clearance
Time frame: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Time frame: Baseline to Month 12
PK parameters for Cizutamig: half-life
Time frame: Baseline to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cizutamig will be dosed according to the protocol. in people with Thyroid Eye Disease, TED, run by Candid Therapeutics at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Zhuang (+86 13918519658, martin@candidrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events through end of study (time frame: Baseline to Month 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.