Kysa-6: A Phase 2/3, Open-Label, Randomized, Controlled, Multicenter Study of Kyv-101, an Autologous Fully Human Anti-Cd19 Chimeric Antigen Receptor T-Cell (Cd19 Car T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients With Generalized Myasthenia Gravis

Study on Investigational Therapy for Myasthenia Gravis

A
Alex Barboi

Primary Investigator

Enrolling By Invitation
18 years - 75 years
All
Phase 2/3
1 participants needed
2 Locations

Brief description of study

Myasthenia gravis (MG) is a chronic autoimmune disease that affects the neuromuscular junction and is characterized by muscle weakness. B cells play a role in MG, and the disease is characterized by the presence of autoantibodies such as anti-AChR and anti-MuSK antibodies. CD-19 target chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T cells to directly and specifically lyse target cells to effectively deplete both normal and autoreactive B cells in the circulation as well as impacted lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with myasthenia gravis (MG).
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

This is a Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis.  Safety and tolerability of KYV-101 as assessed by incidence of adverse events (AEs) and laboratory abnormalities [Time Frame: Up to 24 months] Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) total score [Time Frame: 24 weeks]

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Generalized Myasthenia Gravis
  • Age: 18 years - 75 years
  • Gender: All

Key Inclusion Criteria

  1. Presence of autoantibodies to AChR or MuSK at screening.
  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 pre-dose baseline
  4. QMG total score of ≥11 at screening an confirmed at pre-dose baseline
  5. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (>4 times/year over ≥12 months) 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. No use of FcRn inhibitors within 4 weeks prior to screening

Key Exclusion Criteria

  1. Unable to washout or interrupt autoimmune disease therapy prior to apheresis
  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

This study investigates the use of an investigational therapy for people with generalized myasthenia gravis (MG), a chronic disease that causes muscle weakness. MG affects the connection between nerves and muscles and involves the presence of certain antibodies. The investigational therapy uses special cells called T cells to target and remove certain B cells in the body that are involved in MG.

Participants in this study will receive either the investigational therapy or continue with their usual treatment. The study will look at how safe the investigational therapy is by checking for any side effects and will also measure how well it works by looking at changes in daily activities related to MG.

  • Who can participate: Adults with myasthenia gravis who have certain antibodies and have tried other treatments without success may participate. Participants must meet specific health criteria and not have certain other medical conditions.
  • Study details: Participants will be randomly assigned to receive either the investigational therapy or continue their usual treatment. The study will monitor their health and check for any side effects.
Updated on 26 Feb 2026. Study ID: NEUR-KYVERNA-KYSA6, 28777
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only