ClinicalTrials.gov record
Active, not recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04853576

Public ClinicalTrials.gov record NCT04853576. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects With Severe Sickle Cell Disease

Study identification

NCT ID
NCT04853576
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Editas Medicine, Inc.
Industry
Enrollment
45 participants

Conditions and interventions

Interventions

  • EDIT-301 Genetic

Genetic

Eligibility (public fields only)

Age range
12 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 3, 2021
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update posted
Jan 30, 2025

2021 – 2025

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
18
Facility City State ZIP Site status
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
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
University of Mississippi Medical Center Jackson Mississippi 39216
Hackensack University Medical Center Hackensack New Jersey 07601
Columbia University Medical Center - Department of Pediatrics New York New York 10032
Columbia University Medical Center New York New York 10032
The University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599
Atrium Health Charlotte North Carolina 28204
University Hospitals Rainbow Babies & Children's Hospital Cleveland Ohio 44106
Cleveland Clinic Cleveland Ohio 44195
Nationwide Children's Hospital Columbus Ohio 43205
The James Cancer Hospital Columbus Ohio 43210
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

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04853576, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 30, 2025 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04853576 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →