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New treatment option for Generalized Myasthenia Gravis
Official title Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
ClinicalTrials.gov ID: NCT07215650
What this study is testing
What is Cizutamig?
Cizutamig is an investigational medicine, being studied as a potential treatment for generalized myasthenia gravis.
Also referred to as CND106.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Inadequate response to conventional therapies or lack of effective treatment options, defined as disease recurrence or progression despite treatment...
You likely can't join if
- 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...
- Participation in any investigational trial involving non-biological agents within 4 weeks or 5 half-lives (whichever is longer) of the...
- Participation in any investigational trial involving biological agents within 12 weeks or 5 half-lives (whichever is longer) of the IP before...
- Administration of live vaccines within 4 weeks before screening;
- History of progressive multifocal leukoencephalopathy;
See the full eligibility 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.