Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis
Trial Parameters
Brief Summary
This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.
Eligibility Criteria
Inclusion Criteria: 1. Confirmed gMG diagnosis supported by the following: * Documented report of positive serology testing for either AChR antibodies or MuSK antibodies at screening AND at least one of the following: * History of abnormal neuromuscular transmission test demonstrated by repetitive nerve stimulation or single-fiber electromyography * History of positive acetylcholinesterase inhibitor test * Improvement in MG signs on an oral acetylcholinesterase inhibitor as assessed by the treating physician 2. MGFA Class III-IVa (gMG) at screening 3. Treatment-resistant gMG as defined by: MG-ADL score ≥ 6 (≥50% non-ocular) at screening despite adequate treatment trials with at least two different non-steroidal immunosuppressive drugs given at adequate doses and duration of therapy. 4. If on chronic corticosteroids, must be on a stable dose of corticosteroids for ≥1 month prior to screening and have the ability and willingness to taper to a maximum dose of 10 mg prednisolone daily or e