Myasthenia Gravis Clinical Trials

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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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 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

⁃ Able and willing to attend the necessary visits to the study site

Locations
United States
California
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
University of California, Irvine
RECRUITING
Orange
Stanford University Medical Center
RECRUITING
Palo Alto
Florida
University of Miami
RECRUITING
Miami
Indiana
Indiana University Health
RECRUITING
Indianapolis
Missouri
University of Missouri
RECRUITING
Columbia
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Texas
Houston Methodist Hospital
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Other Locations
Australia
Westmead Institute for Medical Research
RECRUITING
Westmead
Brazil
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Germany
Charite- Universitätsklinikum Berlin
RECRUITING
Berlin
Universitätsklinikum der Ruhr-Universität Bochum
RECRUITING
Bochum
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Medizinische Hochscule Hannover
RECRUITING
Hanover
Friedrich-Schiller-Universität Jena
RECRUITING
Jena
Universitätsklinik Magdeburg
RECRUITING
Magdeburg
Technical University Munich, Klinikum Rechts der Isar
RECRUITING
Munich
Saudi Arabia
King's Faisal Specialist Hospital and Research Center
RECRUITING
Riyadh
United Kingdom
Cambridge University Hospital, Addenbrooke's Hospital
RECRUITING
Cambridge
King's College Hospital
RECRUITING
London
Contact Information
Primary
Kyverna Therapeutics, Inc.
Clinicaltrials@kyvernatx.com
510-925-2484
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2028-09
Participants
Target number of participants: 66
Treatments
Experimental: KYV-101 CAR-T cells with lymphodepletion conditioning
Phase 2: Dosing with KYV-101 CAR-T cells
Experimental: KYV-101 Treatment
Phase 3
Active_comparator: Standard of Care
Phase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks
Related Therapeutic Areas
Sponsors
Leads: Kyverna Therapeutics

This content was sourced from clinicaltrials.gov

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