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 (11) 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 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

Locations
United States
California
University of California, Irvine
RECRUITING
Orange
Stanford University Medical Center
RECRUITING
Palo Alto
Florida
University of Miami
RECRUITING
Miami
Pennsylvania
Allegheny General Hospital
RECRUITING
Pittsburgh
Utah
Intermountain Medical Center
RECRUITING
Murray
Other Locations
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
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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