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New drug hope for muscle weakness disease enters early human testing

NCT ID NCT07215650

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called cizutamig in 44 adults with generalized myasthenia gravis, a condition causing muscle weakness. The main goal is to check safety and how the body processes the drug. Participants must have moderate symptoms and not have responded well to standard treatments.

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 44 people

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

Started

Sep 2025

Expected to finish

Apr 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 years and older

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: 1. At least 18 years old at the time of signing the Informed Consent Form (ICF); 2. Diagnosed with MG, classified as MGFA Class II-IVa, and judged by the investigator as unlikely to require respiratory support during the study; 3. At screening, the Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 5, with non-ocular items accounting for ≥ 50% of the total score, and GMG ≥ 11; 4. Inadequate response to conventional therapies or lack of effective treatment options, defined as disease recurrence or progression despite treatment with corticosteroids, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, methotrexate), or biologics (e.g., rituximab), and/or lack of effective treatment methods. Exclusion Criteria: 1. Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy; 2. Use of any approved immunosuppressive drugs not listed here within 12 weeks or 5 half-lives (whichever is longer) before screening, unless approved by the medical monitor; 3. Participation in any investigational trial involving non-biological agents within 4 weeks or 5 half-lives (whichever is longer) of the investigational product (IP) before screening; 4. Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before screening; 5. Administration of live vaccines within 4 weeks before screening; 6. History of progressive multifocal leukoencephalopathy; 7. History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditary complement deficiency; 8. Presence of one or more significant concurrent diseases, as judged by the investigator, including but not limited to: 1. Poorly controlled diabetes 2. Chronic kidney disease stages IIIb, IV, or V 3. Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) or respiratory failure 9. Any severe medical condition or clinically significant laboratory abnormality that, in the judgment of the investigator or medical monitor, would compromise the patient's safe participation and completion of the study or may affect protocol compliance or interpretation of study results.

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Conditions

The condition(s) this trial relates to.

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

    10 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

  • Huashan Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • The Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • The First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Tianjin Medical University General Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Union Hospital Affiliated to Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, China

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