EDIT-301: Administered by IV infusion after myeloablative conditioning with busulfan.
Study summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of treatment with EDIT-301 in adult and adolescent participants with severe sickle cell disease (SCD).
Eligibility
Sex
ALL
Min age
12 Years
Max age
50 Years
Healthy volunteers
No
Key Inclusion Criteria:
Diagnosis of severe sickle cell disease as defined by:
* Documented SCD genotype (βS/βS, βS/β0, βS/β+, or others) and
* History of at least two severe vaso-occlusive events per year requiring medical attention despite hydroxyurea or other supportive care measures in the two year-period prior to provision of informed consent or assent, as applicable
Karnofsky (for subjects \>16 years of age) or Lansky (for subjects ≤ 16 years of age) Performance Status ≥ 80%
Normal transcranial doppler velocity in subjects 16 years of age or younger
Key Exclusion Criteria:
* Available 10/10 HLA-matched related donor
* Prior HSCT or contraindications to autologous HSCT
* Any contraindications to the use of plerixafor during the mobilization of hematopoietic stem cells (HSCs) and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients
* Unable to receive red blood cell (RBC) transfusion for any reason
* Unable or unwilling to comply with standard of care changes in background medical treatment in preparation of, during, or following HSCT, including and not limited to discontinuation of hydroxyurea, voxelotor, crizanlizumab, or L-glutamine
* Any history of severe cerebral vasculopathy
* Inadequate end organ function
* Advanced liver disease
* Any prior or current malignancy or immunodeficiency disorder
* Immediate family member with a known or suspected Familial Cancer Syndrome
* Clinically significant and active bacterial, viral, fungal, or parasitic infection
Other protocol defined inclusion/exclusion criteria may apply
Primary outcome measure(s)
Proportion of subjects achieving complete resolution of severe vaso-occlusive events (VOEs) — from Month 6 through Month 18 post EDIT-301 infusion
Trial sites (24)
Facility
City
Region
Status
UCSF Benioff Children's Hospital
Oakland
California
Children's Hospital Colorado
Aurora
Colorado
Smilow Cancer Hospital
New Haven
Connecticut
Johns Hopkins All Children's Hospital
St. Petersburg
Florida
Children's Healthcare of Atlanta
Atlanta
Georgia
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Illinois
University of Mississippi Medical Center
Jackson
Mississippi
Hackensack University Medical Center
Hackensack
New Jersey
Columbia University Medical Center - Department of Pediatrics
New York
New York
Columbia University Medical Center
New York
New York
The University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Atrium Health
Charlotte
North Carolina
University Hospitals Rainbow Babies & Children's Hospital
Cleveland
Ohio
Cleveland Clinic
Cleveland
Ohio
Nationwide Children's Hospital
Columbus
Ohio
The James Cancer Hospital
Columbus
Ohio
Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
Tristar Medical Group Children's Specialists/Sarah Cannon Center for Blood Cancers
Nashville
Tennessee
Texas Oncology - Baylor Charles A. Sammons Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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