Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

Official title

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)

Overview

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

• Drug Cizutamig
  Cizutamig will be dosed according to the protocol

Primary outcome measures

• Incidence 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]

Secondary outcome measures (6)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Huashan Hospital Affiliated to Fudan University — Shanghai

Identifiers

NCT: NCT07215650 · CND106-107

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗