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 (gMG)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Incidence and severity of treatment-emergent adverse events through end of study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cizutamig
干预措施: Cizutamig (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events through end of study
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: body temperature
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: heart rate
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: respiratory rate
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: blood pressure
时间窗: Baseline to Month 12
Changes from baseline in vital signs through end of study: pulse oximetry
时间窗: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: QRS interval
时间窗: Baseline to Month 12
Changes from baseline in ECG parameters through end of study: PR interval
时间窗: Baseline to Month12
Changes from baseline in ECG parameters through end of study: QTcF interval
时间窗: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: serum chemistry
时间窗: Baseline to Month 12
Changes from baseline in safety laboratory assessments through end of study: hematology
时间窗: Baseline to Month 12
次要结局
- 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)