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A Study to Evaluate Safety, Tolerability, and Efficacy of AB-1009 Gene Therapy (GAA Gene) in Adult Participants With Late-Onset Pompe Disease (PROGRESS-GT LOPD)

StatusRecruiting
PhasePhase 1/2
SponsorAskBio Inc
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from AskBio Inc

Record History

  1. Primary endpoint(s) modified Eligibility criteria expanded, about 56 words · Secondary endpoints expanded, about 169 words · Site details revised at 1 of 9 sites · 1 morev11 Show 4 more changesShow less
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints expanded, about 169 words
    • Site details revised at 1 of 9 sites
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 10 to 9v10
  3. Start date: Feb 10, 2026 to Apr 15, 2026v9
  4. Study sites revised (10)v8 See this version in full on ClinicalTrials.gov ↗
  5. Site contacts updated at 1 of 10 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Site details revised at 1 of 10 sitesv6
  2. Start date changed from estimate of Jan 2026 to Feb 10, 2026 Site contacts updated at 1 of 10 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 1 of 10 sites
  3. Site contacts updated at 1 of 10 sitesv4
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2025 to Jan 2026 · Site details revised at 10 of 10 sitesv3 Show 2 more changesShow less
    • Start date: Dec 2025 to Jan 2026
    • Site details revised at 10 of 10 sites
  5. Site contacts updated at 1 of 10 sitesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AskBio Inc
9 trials monitored
See 3 trials at risk
This is a single-arm, open-label, dose-escalation study to evaluate the safety, tolerability and efficacy of a single intravenous infusion of AB-1009 in adult participants with late-onset Pompe disease (LOPD).
Trial Details
NCT Number NCT07282847
Lead Sponsor AskBio Inc
Collaborators: Bayer
Conditions Pompe Disease (Late-onset), Pompe Disease Late-Onset, LOPD
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov