Actively Recruiting
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
Led by Kyverna Therapeutics · Updated on 2026-05-13
66
Participants Needed
16
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis
CONDITIONS
Official Title
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Quantitative Myasthenia Gravis (QMG) total score of 11 at screening and confirmed at baseline visit
- Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis or immunoglobulin to control symptoms
- On a stable dose of glucocorticoids and/or other immunotherapies for at least 1 month prior to screening; stable dose of azathioprine for at least 2 months prior to screening
- No change in dose of acetylcholinesterase inhibitors for at least 2 weeks prior to screening
- No use of intravenous immune globulin (IVIG) or plasmapheresis within 4 weeks of screening or pre-dose baseline unless part of standard care
- No use of rituximab or other anti-CD20 or CD19 monoclonal antibody within 12 weeks prior to screening
- Able and willing to attend necessary study visits
You will not qualify if you...
- Unable to stop or interrupt autoimmune disease therapy before apheresis and/or baseline if required
- Co-occurring neurological autoimmune diseases affecting muscles or neuromuscular junction such as Lambert-Eaton Myasthenic Syndrome, myositis, myopathy, or motor neuropathy
- History of stroke with residual effects or risk of recurrence, seizures, neurodegenerative disease, unexplained or recent altered mental status, or uncontrolled/severe psychiatric disease
- Any serious or uncontrolled medical condition posing safety risks or interfering with the study, including significant heart or lung disease
- History of primary immunodeficiency, organ or bone marrow transplant, or splenectomy
- Active or uncontrolled infections including viral, bacterial, or fungal
- Thymectomy less than 12 months before screening or planned during the study
- Prior treatment with gene therapy or cellular immunotherapy requiring vector integration
- Requirement for chronic anticoagulation therapy that cannot be stopped for medical procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Stanford University Medical Center
Palo Alto, California, United States, 94305
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33149
Actively Recruiting
4
Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
6
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
8
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
9
Westmead Institute for Medical Research
Westmead, Australia
Actively Recruiting
10
Hospital Israelita Albert Einstein
São Paulo, Brazil
Actively Recruiting
11
Charite- Universitätsklinikum Berlin
Berlin, Germany
Actively Recruiting
12
Universitätsklinikum der Ruhr-Universität Bochum
Bochum, Germany
Actively Recruiting
13
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
14
Medizinische Hochscule Hannover
Hanover, Germany
Actively Recruiting
15
Friedrich-Schiller-Universität Jena
Jena, Germany
Actively Recruiting
16
Universitätsklinik Magdeburg
Magdeburg, Germany
Actively Recruiting
Research Team
K
Kyverna Therapeutics, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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