A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301
Part of paid clinical trials in Oakland, California.
- Sponsor
- Editas Medicine, Inc.
- Study ID
- NCT06363760
- Status
- Enrolling By Invitation
Conditions
- Hemoglobinopathies
- Sickle Cell Disease
- Transfusion-dependent Beta-Thalassemia
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Safety and efficacy assessments — OTHERAssessed throughout the duration of the study.
Study Details
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 Dates
- Start date
- Jun 17, 2024
- Status verified
- Mar 2025
- Primary completion
- Aug 31, 2040
- Completion
- Aug 31, 2040
Study Design
- Enrollment
- 54 participants (estimated)
Arms
- Arm: All participantsAll participants who complete or discontinue one of the parent studies (EM-SCD-301-001 or EDIT-301-BThal-001)
Primary Outcome Measure
Adverse events of special interest (AESI) [ Time Frame: up to 15 years post EDIT-301 infusion ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF Benioff Children's Hospital | Oakland | California | 94609 | - |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | - |
| Smilow Cancer Hospital | New Haven | Connecticut | 06511 | - |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | - |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | - |
| University of Minnesota | Minneapolis | Minnesota | 55410 | - |
| Columbia University Medical Center | New York | New York | 10032 | - |
| Columbia University Medical Center - Department of Pediatrics | New York | New York | 10032 | - |
| Atrium Health | Charlotte | North Carolina | 28204 | - |
| Cleveland Clinic | Cleveland | Ohio | 44195 | - |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | - |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | - |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | - |
| Tristar Medical Group Children's Specialists/Sarah Cannon Center for Blood Cancers | Nashville | Tennessee | 37203 | - |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | - |
| Cook Children's | Fort Worth | Texas | 76104 | - |
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