New drug hope for muscle weakness disease enters early human testing
NCT ID NCT07215650
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Huashan Hospital Affiliated to Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, China
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The Affiliated Hospital of Guizhou Medical University
RECRUITINGGuiyang, Guizhou, China
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The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, China
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
RECRUITINGGuangzhou, Guangdong, China
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The First Hospital of Jilin University
RECRUITINGChangchun, Jilin, China
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The First Hospital of Shanxi Medical University
RECRUITINGTaiyuan, Shanxi, China
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The Third Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, China
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Tianjin Medical University General Hospital
RECRUITINGTianjin, Tianjin Municipality, China
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Union Hospital Affiliated to Fujian Medical University
RECRUITINGFuzhou, Fujian, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug offer Long-Term relief for muscle weakness?
- Can a new drug ease the muscle weakness of myasthenia gravis?
- Engineered immune cells take aim at debilitating muscle weakness
- New hope for myasthenia gravis: experimental drug CNP-106 enters human trials
- New hope for myasthenia gravis patients: experimental drug enters phase 2 trial
- New drug trial aims to ease muscle weakness in rare disease