Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)
ConditionMyasthaenia Gravis
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongming Qiu
About this trial
The goal of this clinical trial is to evaluating the efficacy and safety of Blinatumomab in the treatment of refractory myasthenia gravis and exploring the immunological mechanisms of Blinatumomab therapy in refractory myasthenia gravis. The main questions it aims to answer are:
Will Blinatumomab improve the symptoms of participants? What medical problems do participants have when using Blinatumomab?
Participants will:
Continuous intravenous infusion of Blinatumomab for 5 days, pause for one week, and continue continuous intravenous infusion for 5 days Visit the clinic once every 1 month for checkups and tests Keep a diary of their symptoms
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old ≤ Age ≤ 75 years old
patients with a Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score of 6 or higher, and an ocular muscle score constituting less than 50% of the total score
after receiving an adequate course of at least two conventional immunotherapeutic drugs (including both steroidal and non-steroidal immunosuppressants), the Post-Intervention Status (PIS) remains unchanged or worsens; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the PIS improves, but the MG-ADL score is still ≥6 points and persists for at least half a year; or after receiving an adequate course of at least two conventional immunotherapeutic drugs, the PIS is in remission or improvement, yet during the regular tapering of immunotherapeutic drugs, there are still at least two annual exacerbations of disease symptoms (MG-ADL score ≥6 points); or after the occurrence of a crisis, despite multiple immunotherapies such as intravenous immunoglobulin, plasmapheresis, and high-dose intravenous methylprednisolone, and active infection control, the patient still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days
positive for anti-AChR, and/or anti-MuSK, and/or anti-LRP4 antibodies.
Disqualifiers
pregnant or lactating women
individuals with an allergy to Blinatumomab
individuals who have undergone thymectomy within the 12 months prior to baseline or who are planning to have a thymectomy during the 12-week study period
individuals who have received biologic agents targeting CD19 or CD20 within 6 months prior to baseline are eligible for enrollment (subjects with CD19 or CD20 positive B cell counts above the lower limit of normal are allowed to participate)
Trial design
Design model
Single group
Treatments tested in this trial
Blinatumomab
DrugThe initial dose is 9 µ g, administered intravenously continuously for 5 days, with a total dose of 38.5 µ g. After stopping the medication for one week, the patient received a second infusion of Blinatumomab for a total of 5 days, with a total dose of 38.5 µ g.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale
The minimum value is 0, and maximum value is 24. higher scores mean a worse outcome. The primary endpoint is the proportion of patients who achieved a reduction of at least 2 points in the MG-ADL score by week 12 and did not undergo rescue therapy.
Time frame
At the 12th weekLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: