Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
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.
| Condition(s) | Generalized Myasthenia Gravis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 histor |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Candid Therapeutics |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-09-16 |
| NCT ID | NCT07215650 |
| Official listing | https://clinicaltrials.gov/study/NCT07215650 |