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New treatment option for Myasthenia Gravis
Official title KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT06193889
What this study is testing
What is Standard lymphodepletion regimen?
Standard lymphodepletion regimen is an investigational medicine, being studied as a potential treatment for myasthenia gravis.
Also referred to as Cyclophosphamide, Fludarabine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Key 1. 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
- QMG total score of ≥11 at screening an confirmed at baseline visit
- Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic...
You likely can't join if
- Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required
- Co-occurring neurological autoimmune disease (ie, Lambert-Eaton Myasthenic Syndrome) or any disease affecting the neuromuscular junction or muscle...
- History of stroke (with residual sequalae and/or risk for recurrence), seizure (even if well controlled on antiepileptics), neurodegenerative...
- Any serious and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study...
- 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
See the full eligibility criteria
- Key 1. 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
- QMG total score of ≥11 at screening an 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 IVIG (or subcutaneous or intramuscular Ig) to control...
- 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
- Able and willing to attend the necessary visits to the study site Key
- Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Miami, Florida, United States
- Indianapolis, Indiana, United States
- Columbia, Missouri, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Murray, Utah, United States
- Westmead, Australia
- São Paulo, Brazil
- Berlin, Germany
- Bochum, Germany
- Hamburg, Germany
- Hanover, Germany
- Jena, Germany
- Magdeburg, Germany
- Munich, Germany
- Riyadh, Kindom of Saudi Arabia, Saudi Arabia
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Palo Alto, California, United States; Miami, Florida, United States; Indianapolis, Indiana, United States; Columbia, Missouri, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.