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.
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
MGFA Class III-IVa (gMG) at screening
Exclusively ocular myasthenia gravis (MGFA I), mild symptoms (MGFA II), or severe bulbar disease or MG crisis, MGFA Class IVb or V at screening
History of bone marrow/hematopoietic stem cell or solid organ transplantation.
Clinically significant active, opportunistic, chronic or recurrent infection (including positive for hepatitis B or hepatitis C) confirmed by clinical evidence, imaging, or positive laboratory tests one month prior to leukapheresis
Other uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, at screening