Actively Recruiting
Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
Led by Candid Therapeutics · Updated on 2025-11-17
44
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of signing the Informed Consent Form
- Diagnosed with Myasthenia Gravis classified as MGFA Class II-IVa and unlikely to require respiratory support during the study
- Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 5 or higher at screening, with non-ocular items accounting for at least 50% of the total score and GMG score of 11 or higher
- Inadequate response or lack of effective treatment options with corticosteroids, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, methotrexate), or biologics (e.g., rituximab)
You will not qualify if you...
- History of CAR-T or TCE therapy targeting any antigen or BCMA-targeted therapy
- Use of any approved immunosuppressive drugs not listed within 12 weeks or 5 half-lives before screening unless approved by the medical monitor
- Participation in investigational trials involving non-biological agents within 4 weeks or 5 half-lives before screening
- Participation in investigational trials involving biological agents within 12 weeks or 5 half-lives before screening
- Administration of live vaccines within 4 weeks before screening
- History of progressive multifocal leukoencephalopathy
- History of primary immunodeficiency or hereditary complement deficiency
- Presence of significant concurrent diseases such as poorly controlled diabetes, chronic kidney disease stages IIIb to V, or severe chronic pulmonary disease requiring supplemental oxygen or respiratory failure
- Any severe medical condition or clinically significant laboratory abnormality that would compromise safe participation or affect study compliance or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
xiao dai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here