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 — DRUG
    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 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 group
    Talquetamab

Primary Outcome Measure

MG-ADL score [ Time Frame: baseline, and 1-6 months ]