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RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Suspended to Active, Not Recruitingv4
  2. Trial status: Recruiting to Suspended Sponsor's reason: The FDA placed a clinical hold on RGX-121, for the treatment of MPSII, following the report of a single case of neoplasm (intraventricular… Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 19, 2025 to Nov 25, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Nov 19, 2025 to Nov 25, 2025
    • Site details revised
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system. This study is a safety, efficacy, and pharmacodynamic dose ranging study to determine whether RGX-121 is safe, effective and well-tolerated by patients with MPS II (Hunter Syndrome)
Trial Details
NCT Number NCT07236606
Lead Sponsor REGENXBIO Inc.
Conditions MPS II, Hunter Syndrome (MPS II)
Enrollment 2 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov