KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

Exclusion Criteria9

• Unable to washout or interrupt autoimmune disease therapy prior to apheresis
• Co-occurring neurological autoimmune disease (ie, Lambert-Eaton Myasthenic Syndrome) or any disease affecting the neuromuscular junction or muscle causing weakness (eg, myositis, myopathy, motor neuropathy)
• History of stroke (with residual sequalae and/or risk for recurrence), seizure (even if well controlled on antiepileptics), neurodegenerative disease, altered mental status (unexplained and/or recent/current), or uncontrolled/severe psychiatric disease
• Any serious and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, including but not limited to, clinically significant cardiac or pulmonary disease
• History of primary immunodeficiency, organ or allogeneic bone marrow transplant, or splenectomy
• Active, uncontrolled, viral, bacterial, or systemic fungal infection or recent history of repeated infections
• Thymectomy \<12 months of screening or planned during the study
• Prior treatment with gene therapy product or cellular immunotherapy (eg, CAR T) requiring vector integration and directed at any target
• Patients requiring chronic anticoagulation therapy that cannot be discontinued for medical procedures