A Study Evaluating the Safety and Efficacy of EDIT-301 in Participants With Severe Sickle Cell Disease (RUBY)
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
45estimated
Sites
24
Countries
Canada, 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 | 2021-05-04 | actual | When the study began enrolling |
| Primary completion | Aug 2025 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2025 | estimated | The whole study's end, after follow-up |
| First posted | 2021-04-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-01-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Sickle Cell Disease
- Hemoglobinopathies
Intervention
- Genetic: EDIT-301 — also filed as renizgamglogene autogedtemcel, reni-cel
Primary outcome
what the primary-completion date above is the date OFProportion of subjects achieving complete resolution of severe vaso-occlusive events (VOEs)
measured from Month 6 through Month 18 post EDIT-301 infusion
Publications
- PMID 41931047 — 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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