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Clinical Trials in the USA / NCT04853576
Active, not recruiting Phase 1/2

A Study Evaluating the Safety and Efficacy of EDIT-301 in Participants With Severe Sickle Cell Disease (RUBY)

NCT04853576 · tracked via the Priya Life Science USA tracker
Sponsor
Editas Medicine, Inc.
Phase
Phase 1/2
Started
2021-05-04
Last updated
2025-01-31

Condition(s) studied

Sickle Cell DiseaseHemoglobinopathies

Investigational drug(s) / intervention(s)

EDIT-301

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)

Trial sites (24)

FacilityCityRegionStatus
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 Dallas Texas
Cook Children's Fort Worth Texas
Ottawa Hospital Research Institute Ottawa Ontario
Princess Margaret Cancer Centre Toronto Ontario
Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec

More Editas Medicine, Inc. trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT04853576 on ClinicalTrials.gov ↗ ← All trials in the USA