ACTIVE_NOT_RECRUITING

BEACON: A Study Evaluating the Safety and Efficacy of BEAM-101 in Patients With Severe Sickle Cell Disease

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Conditions

Sickle Cell DiseaseGene EditingSickle CellSevere Sickle Cell

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, single-arm, multicenter, Phase 1/2 study evaluating the safety and efficacy of the administration of autologous base edited CD34+ HSPCs (BEAM-101) in patients with severe SCD

Official Title

A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients With Sickle Cell Disease and Severe Vaso-Occlusive Crises (Beacon Trial)

Quick Facts

Study Start:2022-08-30
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05456880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
University of Miami
Miami, Florida, 33136-1005
United States
Children's Healthcare of Atlanta - Aflac Cancer and Blood Disorders Center - Egleston Hospital
Atlanta, Georgia, 30329
United States
Boston Children's Hospital
Boston, Massachusetts, 02215
United States
Henry Ford Cancer Center
Detroit, Michigan, 48202
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Beam Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-30
Study Completion Date2028-02

Study Record Updates

Study Start Date2022-08-30
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Gene Editing
  • Sickle Cell
  • Severe Sickle Cell

Additional Relevant MeSH Terms

  • Sickle Cell Disease