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

Enrolling by invitation

Conditions studied: Sickle Cell Disease, Transfusion-dependent Beta-Thalassemia, Hemoglobinopathies

In brief

The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301.

Key facts

Study ID

NCT06363760

Run by

Editas Medicine, Inc.

People needed

54

Starts

2024-06-17

Expected to finish

2040-08-01

Last updated by the study team

2025-04-02

Who can join

Age: 12 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSF Benioff Children's Hospital — Oakland, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Smilow Cancer Hospital — New Haven, Connecticut, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Columbia University Medical Center - Department of Pediatrics — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Tristar Medical Group Children's Specialists/Sarah Cannon Center for Blood Cancers — Nashville, Tennessee, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Cook Children's — Fort Worth, Texas, United States
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
• Princess Margaret Cancer Centre-University Health Network — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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