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ISP-001: Sleeping Beauty Transposon-Engineered B Cells for MPS I

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor Site contacts updated at 1 of 2 sitesv12
  2. Notable Enrollment target: 2 to 11v11 Show 5 more changesShow less
    • Primary completion date: Jun 1, 2025 to Jun 1, 2029
    • Study completion date: Jun 1, 2039 to Jun 1, 2044
    • Eligibility criteria revised
    • Study arms: 1 to 2
    • Study description shortened, about 1 word
  3. Minor Re-verified, no change to tracked fieldsv10
  4. Minor Site contacts updated at 1 of 2 sitesv9
  5. Minor Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Study sites: 1 to 2v7
  2. Notable Primary completion date: Apr 1, 2024 to Jun 1, 2025
    • Study completion date: Oct 1, 2024 to Jun 1, 2039
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2023 to Apr 12, 2023
    • Site details revised
    v5
  4. Minor Secondary endpoints: details revised at 1 of 6 entriesv4
  5. Minor Secondary endpoints: details revised at 1 of 6 entriesv3
  6. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A first-in-human study using ISP-001 in patients with Mucopolysaccharidosis Type I Hurler-Scheie and Scheie.
Trial Details
NCT Number NCT05682144
Lead Sponsor Immusoft of CA, Inc.
Conditions
(from sponsor)
Mucopolysaccharidosis IH/S, Mucopolysaccharidosis IS
Related terms Mucopolysaccharidosis I
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov