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A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301

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NCT06363760 · readout ≤ 5,126 d

Sponsored by Editas Medicine, Inc. (industry) · EDIT — their whole pipeline →.

Phase
Status
Enrolling by invitation
Study type
Observational
Enrollment
54estimated
Sites
18
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
DateFiledBasisWhat it is
Start2024-06-17actualWhen the study began enrolling
Primary completionAug 2040estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionAug 2040estimatedThe whole study's end, after follow-up
First posted2024-04-12actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-04-02actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Sickle Cell Disease
  • Transfusion-dependent Beta-Thalassemia
  • Hemoglobinopathies

Intervention

  • Other: Safety and efficacy assessments

Primary outcomes

what the primary-completion date above is the date OF
Adverse events of special interest (AESI)
measured up to 15 years post EDIT-301 infusion
Adverse events of interest (AEI)
measured up to 15 years post EDIT-301 infusion
All-cause mortality
measured up to 15 years post EDIT-301 infusion
Adverse events (AEs) related to EDIT-301
measured up to 15 years post EDIT-301 infusion
Serious adverse events (SAEs)
measured up to 15 years post EDIT-301 infusion

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