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

Plain-language summary

This study follows patients with sickle cell disease or transfusion-dependent β-thalassemia who previously received the gene therapy EDIT-301, to monitor its long-term safety and effectiveness. It enrolls participants who received an EDIT-301 infusion as part of a clinical study. It is a follow-up study without a designated phase and is enrolling by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

Editas Medicine, Inc.

Intervention

Safety and efficacy assessments

Start date

6/17/2024

Estimated completion

8/1/2040

Countries

United States, Canada

Related genes

Locations

• Oakland, United States
• Aurora, United States
• New Haven, United States
• St. Petersburg, United States
• Atlanta, United States
• Minneapolis, United States
• New York, United States
• New York, United States
• Charlotte, United States
• Cleveland, United States
• Columbus, United States
• Philadelphia, United States
• Charleston, United States
• Nashville, United States
• Dallas, United States
• Fort Worth, United States
• Ottawa, Canada
• Toronto, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Participant must have received an EDIT-301 infusion as part of a clinical study.
* Participant or legal representative/guardian (if applicable) must sign and date the informed consent form (ICF) or assent, if applicable for this long-term follow-up study.

Exclusion Criteria:

* Participant is still actively enrolled in an EDIT-301 treatment study and has not yet met eligibility for long term follow-up in this study.