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A Phase 1/2 Open-Label, Multicenter Dose-Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of PBKR03 Administered to Pediatric Subjects With Early Infantile Krabbe Disease (Globoid Cell Leukodystrophy)

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A Phase 1/2 Open-Label, Multicenter Dose-Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of PBKR03 Administered to Pediatric Subjects With Early Infantile Krabbe Disease (Globoid Cell Leukodystrophy)

Status: Suspended
Phase of Trial: Phase I/II

Latest Information Update: 16 Aug 2024

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At a glance

  • Drugs PBKR 03 (Primary)
  • Indications Globoid cell leukodystrophy
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms GALax-C
  • Sponsors Passage Bio

    • Most Recent Events

    • 08 Aug 2024 According to a Passage Bio media release, following a restructuring of the original agreement of Passage Bio with the University of Pennsylvania about its Gene Therapy Program, a research, collaboration, and license agreement with GEMMA Biotherapeutics was finalized. Consequently, GEMMA Biotherapeutics received an exclusive, worldwide license for all future development of PBKR-03 for the treatment of Krabbe disease, and 2 other drugs.
    • 16 Jan 2024 Status changed from active, no longer recruiting to suspended.
    • 06 Jul 2023 This trial has been discontinued in Netherlands, according to the European Clinical Trials Database record.

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