Back to Trials
NCT07373639Recruiting

A Long-term Follow-up Study in Patients Who Received BEAM-101

Beam Therapeutics Inc.

Start Date

12/15/2025

Completion Date

2/12/2043

Summary

This is a Long-term Follow-up (LTFU) study in patients who received BEAM-101 in the parent study (Study BTX-AUT-001). Eligible patients who received BEAM-101 will be asked to participate in this LTFU study prior to completing Study BTX-AUT-001. Patients who enter into this study will be followed for 13 years (a total of 15 years after receiving BEAM-101).

Detailed Description

Patients who were treated with BEAM-101 in Study BTX-AUT-001 will be asked to sign an informed consent form (ICF) to enter this LTFU study (during the EOS/Month 24 visit for BTX-AUT-001). Patients in this study will have periodic safety and efficacy assessments per the schedule of assessments (SoA). Visits will occur annually through Year 5 following BEAM-101 administration and then every 3 years through Year 11, with a final visit at Year 15. Virtual/phone call check-in visits will occur every 6 months through Year 5 and then annually thereafter.

Eligibility Criteria

Age Range: 14 years to 37 years

Inclusion Criteria: 1. Have received BEAM-101 in Study BTX-AUT-001 and are in the process of completing that study's end-of-study (EOS) visit. 2. Provide signed, written informed consent according to local institutional review board (IRB)/independent ethics committee (IEC) and institutional requirements. Exclusion Criteria: * There are no exclusion criteria for this study.

Interventions

DRUG

Long-Term Follow-up Study of patients who received BEAM-101

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

HemoglobinopathySickle Cell Disease

Locations

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

Children's Healthcare of Atlanta - Aflac Cancer and Blood Disorders Center- Egleston

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

University Hospitals Clevland Medical Center

Cleveland, Ohio 44106

United States

The Clevland 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