Status:
RECRUITING
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
Lead Sponsor:
Kyverna Therapeutics
Conditions:
Myasthenia Gravis
Generalized Myasthenia Gravis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Presence of autoantibodies to AChR or MuSK at screening.
- 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 pre-dose baseline
- QMG total score of ≥11 at screening an confirmed at pre-dose baseline
- 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
- 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
- No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening
- 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)
- No use of rituximab (or any other anti-CD20 or CD19 monoclonal antibody) within 12 weeks prior to screening
- No use of FcRn inhibitors within 4 weeks prior to screening
- Key Exclusion Criteria
- Unable to washout or interrupt autoimmune disease therapy prior to apheresis
- 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
- History of primary immunodeficiency, organ or allogeneic bone marrow transplant, or splenectomy
- Active, uncontrolled, viral, bacterial, or systemic fungal infection or recent history of repeated infections
- Thymectomy \<12 months of screening or planned during the study
- Prior treatment with gene therapy product or cellular immunotherapy (eg, CAR T) requiring vector integration and directed at any target
- Patients requiring chronic anticoagulation therapy that cannot be discontinued for medical procedures
Exclusion
Key Trial Info
Start Date :
August 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06193889
Start Date
August 28 2024
End Date
September 1 2028
Last Update
November 20 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Irvine
Orange, California, United States, 92868
2
Stanford University Medical Center
Palo Alto, California, United States, 94305
3
University of Miami
Miami, Florida, United States, 33149
4
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107