Blinatumomab for Treatment of Refractory Myasthenia Gravis

Sponsor
Da, Yuwei, M.D.
Study ID
NCT06836973
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blinatumomab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Feb 20, 2025
Start date
Apr 1, 2025
Status verified
Feb 2025
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Blinatumomab

Primary Outcome Measure

Change of Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline [ Time Frame: From baseline to 6 months ]

Central Contacts

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