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Not yet recruitingNCT06684184BLINA-MGUpdated Nov 12, 2024

Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)

A Phase 2/3 interventional study of Blinatumomab in Myasthaenia Gravis, sponsored by Zhongming Qiu. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Zhongming Qiu · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2/3
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Myasthaenia Gravis

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03

In context

Myasthenia Gravis

324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.

This study's planned enrollment of 10 is below the median of 44 across 212 interventional studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

Zhongming Qiu is the lead sponsor of 11 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Drug: Blinatumomab

Interventions

  • DrugBlinatumomab

    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.

06

What researchers measure

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 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06684184
Lead sponsor
Zhongming Qiu
Responsible party
Zhongming Qiu (Professor, Xinqiao Hospital of Chongqing) — Sponsor-investigator
First posted
Nov 12, 2024
Start date
Nov 30, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Nov 12, 2024

Study contacts

Zhaoyou Meng
Contact
mengzhaoyou@tmmu.edu.cn
0086-023-68774449

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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