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ATA-200 Gene Therapy Trial in Patients With LGMDR5

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Phase: Phase 1/2 to Phase 1v10 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 6 to confirmed 4
    • Study sites: 3 to 1
    • Study description shortened, about 65 words
    • Study arms: 2 to 1
    • Study title shortened, about 1 word
  2. Primary completion date: Jul 30, 2026 to Oct 30, 2026
    • Study completion date: Jan 31, 2032 to Jan 31, 2031
    • Site details revised at 1 of 3 sites
    v9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 31, 2025 to Feb 15, 2025
    • Site details revised at 3 of 3 sites
    v8
  4. Start date: Dec 1, 2024 to Jan 31, 2025
    • Primary completion date: Jun 30, 2026 to Jul 30, 2026
    • Study completion date: Dec 31, 2031 to Jan 31, 2032
    v7
  5. Study sites: 2 to 3
    • Eligibility criteria revised
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Start date: May 1, 2024 to Dec 1, 2024
    • Study completion date: Jun 30, 2030 to Dec 31, 2031
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Study Status, Contacts/Locationsv3
  4. Start date: Jan 1, 2024 to May 1, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of ATA-003-GSAR study is to evaluate the safety and tolerability of a single intravenous infusion of ATA-200 in pediatric patients with limb girdle muscular dystrophy type 2c/R5 (LGMD R5).
Trial Details
NCT Number NCT05973630
Lead Sponsor Atamyo Therapeutics
Conditions
(from sponsor)		 LGMD2C
Related terms Limb-girdle muscular dystrophy, type 2C
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov