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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKyverna Therapeutics

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

Treatment groups

66 Participants
are divided into 3 treatment groups

Sponsors and collaborators