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Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT

Study acronym: REKLAIM
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jul 2026 to Nov 2026
    • Site details revised at 3 of 3 sites
    v12
  3. Eligibility criteria expanded, about 171 words
    • Publications: 10 to 11
    v11
  4. Site details revised at 1 of 3 sitesv10
  5. Site details revised at 1 of 3 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 2 to 3v8
  2. Secondary endpoint revisedv7
  3. 2 versions Re-verified since Apr 10, 2024, no change to tracked fieldsv5-v6
  4. Primary and study completion dates: Dec 2025 to Jul 2026v4 Show 7 more changesShow less
    • Enrollment target: 12 to 9
    • Eligibility criteria expanded, about 92 words
    • Secondary endpoint revised
    • Study description expanded, about 43 words
    • Site details revised at 1 of 2 sites
    • Publications: details revised at 1 of 10 entries
    • Study title shortened, about 2 words
  5. Site details revised at 1 of 2 sitesv3
  6. Study sites: 1 to 2
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoint revised
    • Publications: 9 to 10
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a non-blinded, non-randomized dose escalation study of intravenous FBX-101 in which subjects will receive a single infusion of an adeno-associated virus gene therapy product, after more than 21 days of the HSCT (UCBT preferred HSCT source). Data from previously transplanted patients with infantile and late infantile Krabbe disease will be used as a comparator group.
Trial Details
NCT Number NCT05739643
Lead Sponsor Forge Biologics, Inc
Conditions
(from sponsor)		 Krabbe Disease
Related terms Brain Diseases, Brain Diseases, Metabolic, Brain Diseases, Metabolic, Inborn, Central Nervous System Diseases, Demyelinating Diseases, Genetic Diseases, Inborn, Hereditary Central Nervous System Demyelinating Diseases, Leukodystrophy, Globoid Cell, Leukoencephalopathies, Lipid Metabolism Disorders, Lipid Metabolism, Inborn Errors, Lipidoses, Lysosomal Storage Diseases, Lysosomal Storage Diseases, Nervous System, Metabolic Diseases, Metabolism, Inborn Errors, Nervous System Diseases, Sphingolipidoses
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov