New drug cizutamig enters early trial for thyroid eye disease

NCT ID NCT07597200

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called cizutamig in 38 adults with active, moderate-to-severe thyroid eye disease. The main goal is to see if the drug is safe and tolerable, while also checking how the body processes it and whether it shows any signs of helping the condition. Participants will receive the drug and be monitored closely for side effects and changes in their symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cizutamig (a drug)
What this could lead to
If this works, it could point toward a new treatment option for thyroid eye disease, potentially reducing symptoms like bulging eyes and discomfort.
What could go wrong
This is a very early Phase 1b trial with only 38 people, so it's mainly checking safety. The drug may not work well or could have side effects, and much more research is needed before it could become a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Guangdong Provincial People's hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, China

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

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • The Eighth Affiliated Hospital of Southern Medical University (Shunde District People's Hospital of Foshan City)

    RECRUITING

    Foshan, Guangdong, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The Second Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, China

  • The Third Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hubei, China

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