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ATA-100 (Formerly GNT0006) Gene Therapy Trial in Patients With LGMDR9

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Phase: Phase 1/2 to Phase 1v8 Show 12 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 39 to confirmed 6
    • Primary completion date changed from estimate of Oct 2025 to Feb 1, 2025
    • Study completion date: Oct 2030 to Sep 30, 2029
    • Start date: Aug 10, 2022 to Sep 1, 2022
    • Interventions: Day 0: GNT0006 (Other), Day 0: Placebo (Other), Day 365 (year 1): GNT0006 (Other), Day 365 (year 1): Placebo (Other), GNT0006 (Other) to ATA-100 (AAV9 encoding FKRP gene) (Biological)
    • Secondary endpoints revised (10)
    • Study description shortened, about 93 words
    • Site details revised at 3 of 3 sites
    • Study arms: 3 to 2
    • Study title expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv7
  3. Site details revised at 1 of 3 sitesv6
  4. Site contacts updated at 1 of 3 sitesv5
  5. Start date changed from estimate of Aug 2022 to Aug 10, 2022v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2022 to Aug 2022
    • Site details revised at 3 of 3 sites
    v3
  2. Start date: Feb 2022 to May 2022
    • Site contacts updated at 2 of 3 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase 1 dose escalation study to assess tolerability and safety of ATA-100 with 5-year follow-up
Trial Details
NCT Number NCT05224505
Lead Sponsor Atamyo Therapeutics
Conditions
(from sponsor)		 LGMDR9
Related terms Muscular Dystrophy, Limb-Girdle, Type 2I
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov