About this trial
A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis
Eligibility criteria
Qualifiers
Presence of autoantibodies to AChR or MuSK
Myasthenia Gravis Foundation of America (MGFA) Class II-IV
MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit
QMG total score of ≥11 at screening an confirmed at baseline visit
Disqualifiers
Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required
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
Trial design
Treatments tested in this trial
- Standard of Care Treatment
- Standard lymphodepletion regimen
- KYV-101