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

A Long-term Follow-up Study in Patients With Hemoglobinopathy Who Received Autologous CD34+ Edited Hematopoietic Stem Cells

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 37 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 24 visits
  • Time periods mentioned: 13 years
  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients who enter into this study will be followed for 13 years (a total of 15 years after receiving BEAM-101)."
  • "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)."
  • "Virtual/phone call check-in visits will occur every 6 months through Year 5 and then annually thereafter."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people who received BEAM-101 in an earlier study called BTX-AUT-001. Follow-up lasts 13 years, for a total of 15 years after receiving BEAM-101.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Received BEAM-101 in Study BTX-AUT-001 and are completing that study’s final visit.
  • Sign a written form agreeing to join the study, following local ethics and study site rules.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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.

    Study sites (17)

    AL

    AZ

    FL

    GA

    MA

    MI

    MN

    MO

    NJ

    NY

    OH

    PA

    SC

    TN

    WI