NCT06684184Not yet recruitingPhase 2/3
Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)
Safety and Efficacy of Blinatumomab in Refractory Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 30 Nov 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Zhongming Qiu
- Diseases
- Myasthenia gravis
- NCT number
- NCT06684184
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 10
- From 30 Nov 2024 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- within the 3 months prior to baseline, use of Ecuzumab and Tocilizumab
- received intravenous immunoglobulin or plasma exchange therapy within 4 weeks prior to baseline
Other illness
- individuals with an allergy to Blinatumomab
Lab values
- 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)
Other
- pregnant or lactating women
- currently participating in other clinical studies
Who the study is looking for
- 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.
- patient or their legal representative signs an informed consent form in writing
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.