Status:
RECRUITING
Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
Lead Sponsor:
Candid Therapeutics
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Generalized Myasthenia Gravis.
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 wi...
Eligibility Criteria
Inclusion
- At least 18 years old at the time of signing the Informed Consent Form (ICF);
- Diagnosed with MG, classified as MGFA Class II-IVa, and judged by the investigator as unlikely to require respiratory support during the study;
- 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;
- 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
- Any history of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy;
- 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;
- 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;
- Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before screening;
- Administration of live vaccines within 4 weeks before screening;
- History of progressive multifocal leukoencephalopathy;
- History of primary immunodeficiency (e.g., hypogammaglobulinemia) or hereditary complement deficiency;
- Presence of one or more significant concurrent diseases, as judged by the investigator, including but not limited to:
- Poorly controlled diabetes
- Chronic kidney disease stages IIIb, IV, or V
- Severe chronic pulmonary disease (e.g., requiring supplemental oxygen) or respiratory failure
- 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.
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07215650
Start Date
September 16 2025
End Date
April 1 2028
Last Update
November 17 2025
Active Locations (1)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China