Anti-CD19 CAR T-Cell Therapy for Refractory Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of KYV-101, an anti-CD19 chimeric antigen receptor T-cell therapy, in adults with refractory generalized myasthenia gravis (MG). The approach targets and depletes both normal and autoreactive B cells, which are implicated in the autoimmune response associated with MG. Participants must have a confirmed diagnosis of MG with specific autoantibodies and have failed multiple prior treatments. The study aims to assess the efficacy and safety of this novel cellular therapy in improving symptoms of MG.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

1. Presence of autoantibodies to AChR or MuSK
2. Myasthenia Gravis Foundation of America (MGFA) Class II-IV
3. MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit
4. QMG total score of ≥11 at screening an confirmed at baseline visit
5. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (or subcutaneous or intramuscular Ig) to control symptoms
6. On a stable dose of glucocorticoids and/or other immunotherapies for ≥1 month prior to screening. For patients treated with azathioprine, a stable dose for ≥2 months prior to screening is required
7. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening
8. No use of intravenous immune globulin (IVIG) or plasmapheresis (PLEX) within 4 weeks of screening or pre-dose baseline (unless this is part of their SOC treatment regimen)
9. No use of rituximab (or any other anti-CD20 or CD19 monoclonal antibody) within 12 weeks prior to screening
10. Able and willing to attend the necessary visits to the study site

Key Exclusion Criteria

1. Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required
2. 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)
3. 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
4. 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
5. History of primary immunodeficiency, organ or allogeneic bone marrow transplant, or splenectomy
6. Active, uncontrolled, viral, bacterial, or systemic fungal infection or recent history of repeated infections
7. Thymectomy \<12 months of screening or planned during the study
8. Prior treatment with gene therapy product or cellular immunotherapy (eg, CAR T) requiring vector integration and directed at any target
9. Patients requiring chronic anticoagulation therapy that cannot be discontinued for medical procedures

Where it's running

• Ronald Reagan UCLA Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Irvine
  Orange, California, United States Recruiting
• Stanford University Medical Center
  Palo Alto, California, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Indiana University Health
  Indianapolis, Indiana, United States Recruiting
• University of Missouri
  Columbia, Missouri, United States Recruiting

Study contacts

• Study coordinator: Kyverna Therapeutics, Inc.
• Email: Clinicaltrials@kyvernatx.com
• Phone: 510-925-2484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.