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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Cizutamig will be dosed according to the protocol
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence and severity of treatment-emergent adverse events through end of study
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
Time frame: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
Time frame: Baseline to Month12
Changes from baseline in ECG parameters through end of study: QRS interval
Time frame: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QTcF interval
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
Time frame: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
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Time frame: Baseline to Month 12
Pharmacokinetic (PK) parameters for Cizutamig: Cmax
Time frame: Baseline to Month 12
PK parameters for Cizutamig: time of maximum concentration
Time frame: Baseline to Month 12
PK parameters for Cizutamig: area under the concentration-time curve
Time frame: Baseline to Month 12
PK parameters for Cizutamig: clearance
Time frame: Baseline to Month 12
PK parameters for Cizutamig: volume of distribution
Time frame: Baseline to Month 12
PK parameters for Cizutamig: half-life
Time frame: Baseline to Month 12