Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)

NCT06684184 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024-254-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myasthaenia Gravis

Outcome Measures

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.

  At the 12th week

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

The 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 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• currently participating in other clinical studies

Sponsors & Collaborators

• Zhongming Qiu: lead

MeSH Terms

Interventions

blinatumomab

Central Study Contacts

Zhaoyou Meng

CONTACT

0086-023-68774449; mengzhaoyou@tmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: November 12, 2024
• Study Start: November 30, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share