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).
This is a Phase 1/2 single-arm, open-label, multicenter study evaluating the safety and efficacy of a single unit dose of EDIT-301 for autologous hematopoietic stem cell transplant (HSCT) in subjects with severe SCD. Planned study subjects will be comprised of male and female adult and adolescent subjects with severe SCD, from 12 to 50 years of age, inclusive.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Administered by IV infusion after myeloablative conditioning with busulfan.
Proportion of subjects achieving complete resolution of severe vaso-occlusive events (VOEs)
Time frame: from Month 6 through Month 18 post EDIT-301 infusion
Proportion of subjects achieving complete resolution of VOEs
Time frame: from Month 6 through Month 18 post EDIT-301 infusion
Proportion of subjects with 90% reduction in annualized rate of severe VOE compared to pre-treatment period
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Proportion of subjects with 75% reduction in annualized rate of severe VOE compared to pre-treatment period
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Proportion of subjects with 50% reduction in annualized rate of severe VOE compared to pre-treatment period
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Difference (pre-treatment vs. post-treatment) in annualized rates of severe VOEs
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Difference (pre-treatment vs. post-treatment) in annualized rate of hospitalization for severe VOEs
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Proportion of subjects with sustained HbF ≥ 20% (HbF/Hb) compared with baseline
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Proportion of subjects with mean HbF ≥ 30% (HbF/Hb) compared with baseline
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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
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Hackensack University Medical Center
Hackensack, New Jersey, 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
...and 14 more locations
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Proportion of subjects with mean total Hb ≥ 10 g/dL compared with baseline
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Proportion of subjects with mean total Hb increase from baseline of ≥ 2 g/dL
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Difference (pre-treatment versus post-treatment) in annualized number of units of pRBC transfused for SCD-related indications
Time frame: starting from 6 months up to 2 years post EDIT-301 infusion
Change from baseline in HbF concentration (g/dL)
Time frame: up to 2 years post EDIT-301 infusion
Change from baseline in total Hb concentration (g/dL)
Time frame: up to 2 years post EDIT-301 infusion
Change from baseline in markers of hemolysis (absolute reticulocyte count, indirect bilirubin, lactate dehydrogenase, haptoglobin)
Time frame: up to 2 years post EDIT-301 infusion
Time to neutrophil engraftment (the first day in which 3 consecutive absolute neutrophil count (ANC) ≥ 0.5 x 109/L laboratory values obtained on different days)
Time frame: up to 24 months after EDIT-301 infusion
Time to platelet engraftment (the first day in which 3 consecutive platelets ≥ 50 x 109/L laboratory values obtained for at least 7 days following the last platelet transfusion and 10 days following any administration of thrombopoietin (TPO) mimetics)
Time frame: up to 24 months after EDIT-301 infusion
Frequency and severity of adverse events (AEs)
Time frame: up to 24 months post EDIT-301 infusion