The goal of this clinical trial is to evaluate the efficacy and safety of Blinatumomab in the treatment of refractory myasthenia gravis, with the expectation of offering a new therapeutic option for refractory patients. The main questions it aims to answer are: * Does Blinatumomab improve patients' clinical symptoms? * Is Blinatumomab safe for the treatment of myasthenia gravis? Participants will: * Receive two cycles of intravenous Blinatumomab infusion, each lasting 5 days, with a 1-week interval between cycles. * Visit the clinic once every 4 weeks for checkups and tests. * Keep a diary of their symptoms and the types and dosages of medications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Blinatumomab is used at its starting dose of 9 µg per day and administered as continuous infusion for 5 days (total dose of 38.5 µg). After a 1-week pause, the patients receive a second 5-day infusion with blinatumomab of total 38.5 µg of the drug.
Change of Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline
The MG-ADL scale is an 8-item questionnaire. It is completed by trained interviewers based on the patients' subjective responses. The total score ranges from 0 to 24, with higher scores indicating greater impact of the disease on daily living activities.
Time frame: From baseline to 6 months
Change of Quantitative Myasthenia Gravis (QMG) Scores from baseline
The QMG scale is a 13-item scale used to objectively assess muscle strength and fatigue in patients with myasthenia gravis. The total score ranges from 0 to 39, with higher scores indicating greater disease severity.
Time frame: From baseline to 6 months
Time to achievement of minimal symptom expression (MSE)
The MSE is a quantifiable, patient-reported outcome measure that assesses treatment goals in myasthenia gravis. It is defined as achieving an MG-ADL score of ≤1, indicating that clinical symptoms of MG are at their minimal level.
Time frame: From baseline to 6 months
Change of Myasthenia Gravis Quantity-of-Life Scale (MG-QoL15) from baseline
The MG-QOL15 scale is a 15-item questionnaire designed to assess the impact of myasthenia gravis on patients' daily life, physical function, social well-being, and mental health. The total score ranges from 0 to 60, with higher scores indicating poorer quality of life.
Time frame: From baseline to 6 months
Change of Myasthenia Gravis Composite (MGC) scores from baseline
The MGC scale is a 10-item scale that combines patient self-assessment and physician examination results. Each item is assigned a weight based on factors such as health risks, quality of life, and prognosis. The total score of the scale is 50 points, with higher scores indicating more severe disease.
Time frame: From baseline to 6 months
Change of antibody titers from baseline
MG antibodies are detected at enrollment and the titers of antibodies will be monitored monthly.
Time frame: From baseline to 6 months
Treatment-Related Adverse Events (AEs)
Record all AEs reported by patients during the study period.
Time frame: From baseline to 6 months
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