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A Phase 2, Open-Label, Multicentre Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, in Subjects With Refractory Generalized Myasthenia Gravis (KYSA-6)

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Trial Profile

A Phase 2, Open-Label, Multicentre Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, in Subjects With Refractory Generalized Myasthenia Gravis (KYSA-6)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Mar 2025

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At a glance

  • Drugs KYV-101 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Myasthenia gravis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms KYSA-6
  • Sponsors Kyverna Therapeutics

    • Most Recent Events

    • 13 Jan 2025 According to a Kyverna therapeutics media release, the company expect to report interim Phase 2 data in the second half of 2025 and confirm registrational path with regulators 1H 2025.
    • 20 Sep 2024 Study design presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
    • 18 Sep 2024 According to a Kyverna therapeutics media release, case reports from three phase 3 clinical studies are to be presented at a company symposium titled, ''KYV-101 Unlocking the Potential of CAR T-cell Therapy in Neuroinflammatory Diseases'' to be held at 5:15 pm CET on Sep 18, 2024. The company and investigators will highlight case report experience from 11 patients from these studies.

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