Talquetamab in Patients With Refractory Generalized Myasthenia Gravis
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
- Study ID
- NCT07499323
- Status
- Not Yet Recruiting
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Conditions
- Myasthenia Gravis (MG)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Talquetamab — DRUGEligible 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 Details
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.
Key Dates
- Start date
- Mar 20, 2026
- Status verified
- Apr 2026
- Primary completion
- Mar 20, 2027
- Completion
- Apr 1, 2027
Study Design
- Enrollment
- 2 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: treatment groupTalquetamab
Primary Outcome Measure
MG-ADL score [ Time Frame: baseline, and 1-6 months ]