KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

Part of paid clinical trials in Orange, California.

Sponsor
Kyverna Therapeutics
Study ID
NCT06193889
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis
  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Treatment — DRUG
    Standard of Care Medications Optional Crossover to receive KYV-101 treatment
  • Standard lymphodepletion regimen — DRUG
    Standard lymphodepletion regimen
  • KYV-101 — BIOLOGICAL
    Anti-CD19 CAR-T cell therapy

Study Details

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

Key Dates

Start date
Aug 28, 2024
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2) [ Time Frame: 18 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California, IrvineOrangeCalifornia92868
Study Coordinator
Stanford University Medical CenterPalo AltoCalifornia94305
Study Coordinator
University of MiamiMiamiFlorida33149
Study Coordinator
Indiana University HealthIndianapolisIndiana46202
Study Coordinator
University of MissouriColumbiaMissouri65212
Study Coordinator
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Study Coordinator
Houston Methodist HospitalHoustonTexas77030
Study Coordinator
Intermountain Medical CenterMurrayUtah84107
Study Coordinator

Find similar trials in Orange, CA

By research site
University of California, Irvine· Orange, CAStanford University Medical Center· Palo Alto, CAUniversity of Miami· Miami, FLIndiana University Health· Indianapolis, INUniversity of Missouri· Columbia, MOThomas Jefferson University Hospital· Philadelphia, PA

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