Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cizutamig
  Cizutamig will be dosed according to the protocol

Первичные конечные точки

• Incidence and severity of treatment-emergent adverse events through end of study [Срок оценки: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: body temperature [Срок оценки: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: heart rate [Срок оценки: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: respiratory rate [Срок оценки: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: blood pressure [Срок оценки: Baseline to Month 12]
• Changes from baseline in vital signs through end of study: pulse oximetry [Срок оценки: Baseline to Month 12]
• Changes from baseline in ECG parameters through end of study: PR interval [Срок оценки: Baseline to Month12]
• Changes from baseline in ECG parameters through end of study: QRS interval [Срок оценки: Baseline to Month 12]
• Changes from baseline in ECG parameters through end of study: QTcF interval [Срок оценки: Baseline to Month 12]
• Changes from baseline in safety laboratory assessments through end of study: serum chemistry [Срок оценки: Baseline to Month 12]

Вторичные конечные точки (6)

• Pharmacokinetic (PK) parameters for Cizutamig: Cmax [Срок оценки: Baseline to Month 12]
• PK parameters for Cizutamig: time of maximum concentration [Срок оценки: Baseline to Month 12]
• PK parameters for Cizutamig: area under the concentration-time curve [Срок оценки: Baseline to Month 12]
• PK parameters for Cizutamig: clearance [Срок оценки: Baseline to Month 12]
• PK parameters for Cizutamig: volume of distribution [Срок оценки: Baseline to Month 12]
• PK parameters for Cizutamig: half-life [Срок оценки: Baseline to Month 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital Affiliated to Fudan University — Шанхай

Идентификаторы

NCT: NCT07215650 · CND106-107

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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