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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: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 22 May 2025

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At a glance

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

Most Recent Events

  • 13 May 2025 According to Kyverna Therapeutics media release, the company is on track for topline data in 1H 2026 and biologics license application (BLA) filing now anticipated in 1H 2026.
  • 13 May 2025 Status changed from recruiting to active, no longer recruiting, according to Kyverna Therapeutics media release.
  • 27 Mar 2025 According to Kyverna Therapeutics media release, the company anticipates Completion of enrollment is expected in mid-2025.

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