Myasthenia Gravis (MG)NCT07499323
Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
A study testing Talquetamab in people with Myasthenia Gravis (MG), run by First Affiliated Hospital of Chongqing Medical University.
Trial summary
Myasthenia Gravis (MG) is a chronic autoimmune disease mediated by pathogenic antibodies. Approximately 10%-15% of patients present with refractory status, defined as having an inadequate response to existing therapies or an inability to tolerate the side effects of the medication, highlighting an urgent need for the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myasthenia Gravis (MG)
- What is being tested?
- Talquetamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 1 Apr 2027
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must sign the informed consent form for participation in the study and agree to comply with the study procedures.
- Age 18-70 years.
- Must meet the clinical diagnostic criteria for MG, defined as presenting with a typical pattern of weakness (predominantly affecting proximal muscles, fatiguability, fluctuating severity, worse with prolonged effort and better after rest) and meeting any one of the following three conditions: documented history of abnormal neuromuscular transmission confirmed by single-fiber electromyography or repetitive nerve stimulation; documented history of a positive neostigmine test; or improvement in MG signs following oral administration of an acetylcholinesterase inhibitor. Additionally, the Myasthenia Gravis Foundation of America (MGFA) clinical classification must be II-IV, and the patient must be positive for anti-AChR antibodies.
- Must meet the definition of "refractory myasthenia gravis" according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition): defined as having a suboptimal response to conventional immunotherapeutic drugs, intolerance to or having contraindications for adverse drug reactions, or experiencing frequent disease relapses requiring regular rescue therapy, making it difficult to achieve treatment goals.
- Myasthenia Gravis Activities of Daily Living (MG-ADL, Appendix 1) score ≥6, with >50% of the score derived from non-ocular items.
- Quantitative Myasthenia Gravis (QMG) score (Appendix 2) ≥8, with >50% of the score derived from non-ocular items.
- The dosage of pyridostigmine bromide must be stable for at least 1 week prior to the treatment period.
Who cannot join
- Patients who have had their glucocorticoid dose adjusted, or who have received immunoglobulins, plasma exchange, neonatal Fc receptor inhibitors, or complement inhibitors within ≤4 weeks.
- Patients who have undergone thymectomy, received B-cell depletion therapy, or had their dose of non-steroidal immunosuppressants (such as azathioprine, tacrolimus, mycophenolate mofetil, cyclophosphamide, etc.) adjusted within ≤3 months.
- Patients who have participated in any interventional clinical trial or received investigational treatment within ≤3 months, or within 5 half-lives of the received investigational drug (whichever is longer).
- Patients with concurrent severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction.
- Patients with concurrent chronic infections such as Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus, or Mycobacterium tuberculosis.
About this study
Official title: A Preliminary Case Study to Evaluate the Efficacy and Safety of Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
Myasthenia Gravis (MG) is a chronic autoimmune disease mediated by pathogenic antibodies. Approximately 10%-15% of patients present with refractory status, defined as having an inadequate response to existing therapies or an inability to tolerate the side effects of the medication, highlighting an urgent need for the development of more targeted innovative therapies. Talquetamab is a bispecific antibody that targets G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D) and the Cluster of Differentiation 3 (CD3) molecule on the surface of T cells, thereby inducing T cells to precisely eliminate GPRC5D-positive cells. This study will conduct an exploratory case series to investigate the efficacy and safety of Talquetamab in refractory MG.
- Conditions
- Myasthenia Gravis (MG)
- Being tested
- Talquetamab
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalquetamabDrug
Eligible patients will receive the drug via subcutaneous injection on Days 1, 3, and 5, respectively. The dose will be determined based on body weight measured before administration, according to the following table. A total of 3 doses will be administered. Administration Day and Dose: 0.01 mg/kg in Day 1; 0.06 mg/kg in Day 3; 0.4 mg/kg in Day 5.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Talquetamab Receives: Drug: Talquetamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MG-ADL score
Full scale title:
Myasthenia Gravis Activities of Daily Living Profile (MG-ADL)
Score range: 0-24
A higher score means worse outcomes (greater symptom severity and more impairment in daily functioning).
Measured: baseline, and 1-6 months
Secondary outcomes (1)
QMG score
Full scale title:
Quantitative Myasthenia Gravis Score (QMG), also referred to as the Quantitative Myasthenia Gravis Scale .
Score range:0-39
A higher score means worse outcomes (more severe disease and greater weakness). Conversely, a lower score indicates milder disease or better symptom control .
Measured: baseline and 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion20 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis (MG)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Xiao, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499323
- Sponsor's protocol ID
- KX2026-KYC102-01
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the consent of the project leader and research subjects, after the research is completed (expected to start in May 2026), it can be done via email feixiao81@126.com Contact the project leader to obtain desensitization data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Case Study to Evaluate the Efficacy and Safety of Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07499323
- Acronym / sponsor ID
- KX2026-KYC102-01
- Conditions
- Myasthenia Gravis (MG)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (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.
Myasthenia Gravis (MG) is a chronic autoimmune disease mediated by pathogenic antibodies. Approximately 10%-15% of patients present with refractory status, defined as having an inadequate response to existing therapies or an inability to tolerate the side effects of the medication, highlighting an urgent need for the development of more targeted innovative therapies. Talquetamab is a bispecific antibody that targets G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D) and the Cluster of Differentiation 3 (CD3) molecule on the surface of T cells, thereby inducing T cells to precisely eliminate GPRC5D-positive cells. This study will conduct an exploratory case series to investigate the efficacy and safety of Talquetamab in refractory MG.
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: TalquetamabTalquetamab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must sign the informed consent form for participation in the study and agree to comply with the study procedures.
- Age 18-70 years.
- Must meet the clinical diagnostic criteria for MG, defined as presenting with a typical pattern of weakness (predominantly affecting proximal muscles, fatiguability, fluctuating severity, worse with prolonged effort and better after rest) and meeting any one of the following three conditions: documented history of abnormal neuromuscular transmission confirmed by single-fiber electromyography or repetitive nerve stimulation; documented history of a positive neostigmine test; or improvement in MG signs following oral administration of an acetylcholinesterase inhibitor. Additionally, the Myasthenia Gravis Foundation of America (MGFA) clinical classification must be II-IV, and the patient must be positive for anti-AChR antibodies.
- Must meet the definition of "refractory myasthenia gravis" according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition): defined as having a suboptimal response to conventional immunotherapeutic drugs, intolerance to or having contraindications for adverse drug reactions, or experiencing frequent disease relapses requiring regular rescue therapy, making it difficult to achieve treatment goals.
- Myasthenia Gravis Activities of Daily Living (MG-ADL, Appendix 1) score ≥6, with >50% of the score derived from non-ocular items.
Key exclusion criteria (5 listed)
- Patients who have had their glucocorticoid dose adjusted, or who have received immunoglobulins, plasma exchange, neonatal Fc receptor inhibitors, or complement inhibitors within ≤4 weeks.
- Patients who have undergone thymectomy, received B-cell depletion therapy, or had their dose of non-steroidal immunosuppressants (such as azathioprine, tacrolimus, mycophenolate mofetil, cyclophosphamide, etc.) adjusted within ≤3 months.
- Patients who have participated in any interventional clinical trial or received investigational treatment within ≤3 months, or within 5 half-lives of the received investigational drug (whichever is longer).
- Patients with concurrent severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction.
- Patients with concurrent chronic infections such as Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus, or Mycobacterium tuberculosis.
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 |
|---|---|---|
| TalquetamabEligible patients will receive the drug via subcutaneous injection on Days 1, 3, and 5, respectively. The dose will be determined based on body weight measured before administration, according to the following table. A total of 3 doses will be administered. Administration Day and Dose: 0.01 mg/kg in Day 1; 0.06 mg/kg in Day 3; 0.4 mg/kg in Day 5. | Drug | treatment group |
Primary outcome
MG-ADL score
Time frame: baseline, and 1-6 months
Full scale title: Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Score range: 0-24 A higher score means worse outcomes (greater symptom severity and more impairment in daily functioning).
1 secondary outcome
QMG score
Time frame: baseline and 1-6 months
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 8 Apr 2026.
- Individual participant dataSharing planned: Yes. With the consent of the project leader and research subjects, after the research is completed (expected to start in May 2026), it can be done via email feixiao81@126.com Contact the project leader to obtain desensitization data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Talquetamab in people with Myasthenia Gravis (MG), run by First Affiliated Hospital of Chongqing Medical University.
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 7 inclusion and 5 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 8 Apr 2026. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MG-ADL score (time frame: baseline, and 1-6 months). 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 8 Apr 2026.