Myasthenia Gravis
Conditions
Interventions
Experimental group:Talquetamab injection for subcutaneous use
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient must sign the informed consent form for participating in the study and agree to follow the study procedures; 2. Age 18–70 years; 3. Meet the clinical diagnostic criteria for MG, that is, satisfy the typical weakness pattern (mainly involving the proximal muscles, prone to fatigue, fluctuating severity, morning mild and evening severe, improving after rest), and any one of the following three conditions (confirmed abnormal neuromuscular transmission history through single-fiber electromyography or repetitive nerve stimulation; positive history of neostigmine test; improvement of MG signs after oral acetylcholinesterase inhibitor administration), and be classified as II–IV by the Myasthenia Gravis Foundation of America (MGFA) clinical classification, and have positive anti-AChR antibodies; 4. Meet the definition of "refractory myasthenia gravis" in the "Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition)" (showing poor response to conventional immunotherapy drugs, unable to tolerate adverse drug reactions or having contraindications for use, or having a tendency for frequent relapses, requiring regular remedial treatment, and difficult to achieve treatment goals); 5. The score of daily living ability for myasthenia gravis (Myasthenia Gravis Activities of Daily Living, MG-ADL, Appendix 1) is >= 6 points, and more than 50% comes from non-eye muscle items; 6. The quantitative score of myasthenia gravis (Quantitative Myasthenia Gravis Score, QMG, Appendix 2) is >= 8 points, and more than 50% comes from non-eye muscle items; 7. The dose of pyridostigmine bromide is stable for at least 1 week before the treatment period.
Exclusion criteria
Exclusion criteria: 1. The patient underwent adjustment of glucocorticoid dosage within <= 4 weeks, or received immunoglobulin, plasma exchange, neonatal Fc receptor inhibitors, or complement inhibitors; 2. The patient underwent thymectomy within <= 3 months, or received B-cell depletion therapy, or had dose adjustment of non-hormonal immunosuppressants (such as azathioprine, tacrolimus, mycophenolate mofetil, cyclophosphamide, etc.); 3. The patient participated in any interventional clinical trial or received investigational treatment within <= 3 months, or within the 5 half-lives of the administered investigational drug (whichever is longer); 4. The patient had severe liver, kidney, heart, lung, or coagulation dysfunction; 5. The patient had chronic infections such as human immunodeficiency virus, hepatitis B virus, hepatitis C virus, tuberculosis bacteria, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADL score; | — |
Secondary
| Measure | Time frame |
|---|---|
| QMG score; | — |
Countries
China
Contacts
Public ContactXiao Fei
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed