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KYSA-8: A Phase 2 Open-Label, Single-Arm, Multicenter Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome

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Trial Profile

KYSA-8: A Phase 2 Open-Label, Single-Arm, Multicenter Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs KYV-101 (Primary)
  • Indications Stiff-person syndrome
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms KYSA-8

    • Most Recent Events

    • 27 Mar 2025 According to Kyverna Therapeutics media release, the company anticipates Completion of enrollment is expected in mid-2025.
    • 13 Jan 2025 According to Kyverna Therapeutics media release, the company has done 40% enrollment in pivotal Phase 2 trial with first BLA filing targeted for 2026.
    • 13 Nov 2024 According to Kyverna Therapeutics media release, for KYSA-8 KYV-101 has been granted an RMAT designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

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