Generalized Myasthenia Gravis
Conditions
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 with Generalized Myasthenia Gravis.
Interventions
DRUGCizutamig
Cizutamig will be dosed according to the protocol
Sponsors
Candid Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events through end of study | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: body temperature | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: heart rate | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: respiratory rate | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: blood pressure | Baseline to Month 12 |
| Changes from baseline in vital signs through end of study: pulse oximetry | Baseline to Month 12 |
| Changes from baseline in ECG parameters through end of study: PR interval | Baseline to Month12 |
| Changes from baseline in ECG parameters through end of study: QRS interval | Baseline to Month 12 |
| Changes from baseline in ECG parameters through end of study: QTcF interval | Baseline to Month 12 |
| Changes from baseline in safety laboratory assessments through end of study: serum chemistry | Baseline to Month 12 |
| Changes from baseline in safety laboratory assessments through end of study: hematology | Baseline to Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters for Cizutamig: Cmax | Baseline to Month 12 |
| PK parameters for Cizutamig: time of maximum concentration | Baseline to Month 12 |
| PK parameters for Cizutamig: area under the concentration-time curve | Baseline to Month 12 |
| PK parameters for Cizutamig: clearance | Baseline to Month 12 |
| PK parameters for Cizutamig: volume of distribution | Baseline to Month 12 |
| PK parameters for Cizutamig: half-life | Baseline to Month 12 |
Countries
China
Contacts
CONTACTxiao dai
Outcome results
None listed