Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06559176 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of the Safety and Efficacy of Prime Editing (PM359) in Participants With p47phox Autosomal Recessive Chronic Granulomatous Disease (CGD )

StatusEnrolling by Invitation
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Study description expanded, about 24 words
    v13
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 5 of 5 sites
    v12
  3. Study Identification, Study Status, Outcome Measuresv11
  4. Site details revised at 1 of 5 sitesv10
  5. Site details revised at 1 of 5 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 1 of 5 sitesv8
  2. Primary completion date: Nov 2029 to Jan 2030
    • Study completion date: Dec 2029 to Feb 2030
    • Start date changed from estimate of Nov 2024 to Oct 17, 2024
    • Site details revised at 1 of 5 sites
    v7
  3. Study sites revised (5)v6
  4. Primary completion date: Oct 2029 to Nov 2029
    • Study completion date: Nov 2029 to Dec 2029
    • Start date: Oct 2024 to Nov 2024
    • Site details revised at 1 of 5 sites
    v5
  5. Study sites: 4 to 5
    • Primary completion date: Sep 2029 to Oct 2029
    • Study completion date: Oct 2029 to Nov 2029
    • Start date: Sep 2024 to Oct 2024
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v3
  7. Site contacts updated at 1 of 4 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label, single-arm, multicenter Phase 1/2 study evaluating the safety and efficacy of gene therapy by transplantation of Prime Edited autologous CD34+ stem cells modified ex vivo (PM359) in participants with autosomal recessive Chronic Granulomatous Disease (CGD) caused by mutations in the NCF1 (Neutrophil Cytosolic Factor 1) gene.
Trial Details
NCT Number NCT06559176
Lead Sponsor Prime Medicine, Inc.
Conditions
(from sponsor)		 Chronic Granulomatous Disease, Granulomatous Disease, Chronic
Related terms Granulomatous Disease, Chronic
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov