Myasthaenia GravisPhase 2/3BLINA-MGNCT06684184
Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)
A Phase 2/3 study testing Blinatumomab in people with Myasthaenia Gravis, run by Zhongming Qiu.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myasthaenia Gravis
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 30 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Blinatumomab in Refractory Myasthenia Gravis
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
- Being tested
- Blinatumomab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthaenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongming Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongming Qiu, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684184
- Sponsor's protocol ID
- 2024-254-01
- Acronym
- BLINA-MG
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Blinatumomab in Refractory Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT06684184
- Acronym / sponsor ID
- BLINA-MG / 2024-254-01
- Conditions
- Myasthaenia Gravis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhongming QiuUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Blinatumomab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlinatumomabThe 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. | Drug | Treatment group |
Primary outcome
Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale
Time frame: At the 12th week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Blinatumomab in people with Myasthaenia Gravis, run by Zhongming Qiu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyou Meng (0086-023-68774449, mengzhaoyou@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale (time frame: At the 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.