Cizutamig for adults with generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b, open-label, multicenter study administers cizutamig to adults with generalized myasthenia gravis who have had inadequate responses to standard therapies. The trial focuses on safety and tolerability while measuring pharmacokinetics, pharmacodynamics, and immunogenicity. Investigators will also collect preliminary clinical activity data to look for symptom improvement. Findings will guide dosing and the design of larger efficacy trials if results are promising.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital Affiliated to Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting
• The Third Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: xiao dai
• Email: xiao@candidrx.com
• Phone: +8618521520014

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

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• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.