NCT06193889 KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 66 participants in total. It began in 2024-08-28 with a primary completion date of 2027-09.

Brief Summary

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis

Eligibility Criteria

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

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