A Study of the Safety and Efficacy of Prime Editing (PM359) in Participants With p47phox Autosomal Recessive Chronic Granulomatous Disease (CGD )
← catalyst calendarNCT06559176 · readout ≤ 1,261 d
Sponsored by Prime Medicine, Inc. (industry) · PRME — their whole pipeline →.
Phase
Phase 1/2
Status
Enrolling by invitation
Study type
Interventional
Design
Na · None · Treatment
Enrollment
12estimated
Sites
5
Countries
Canada, United Kingdom, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-17 | actual | When the study began enrolling |
| Primary completion | Jan 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Chronic Granulomatous Disease
- Granulomatous Disease, Chronic
Intervention
- Biological: PM359
Primary outcomes
what the primary-completion date above is the date OFSafety of administration of PM359, as quantified by frequency of adverse events (AEs) after drug product infusion
measured PM359 infusion through Month 12 after PM359 infusion
Percentage of participants with sustained reconstitution of NADPH oxidase activity in neutrophils
measured At Month 6 and Month 12 after PM359 infusion, as compared to baseline
Publications
- PMID 31634902 — cited as background
- PMID 41358590 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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