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
Single group
YTB323
GeneticCAR-T cell suspension for intravenous infusion
Occurrence, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of AE's, including Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANs), changes in Vital Signs, Laboratory parameters, ECG, and neurological status qualifying and reported as AEs.
Plasma Pharmacokinetics (PK) of YTB323 - CMAX
Measured by Cmax - The maximum plasma concentration of YTB323
Plasma Pharmacokinetics (PK) of YTB323 - AUC
Measured by AUC - Area under the curve of YTB323
Plasma Pharmacokinetics (PK) of YTB323 - Tmax
Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of YTB323
Plasma Pharmacokinetics (PK) of YTB323 - Clast
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast)
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