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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cizutamig | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cizutamig | Drug | Cizutamig will be dosed according to the protocol |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiao dai | Contact | +8618521520014 | xiao@candidrx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Baseline to Month 12 |
| Changes from baseline in safety laboratory assessments through end of study: hematology | Baseline to Month 12 |
| 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 |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |