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A Phase 1/2 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With the LentiGlobin BB305 Lentiviral Vector in Subjects With Severe Sickle Cell Disease

Trial Profile

A Phase 1/2 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With the LentiGlobin BB305 Lentiviral Vector in Subjects With Severe Sickle Cell Disease

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 14 Feb 2024

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At a glance

  • Drugs Betibeglogene-autotemcel (Primary)
  • Indications Sickle cell anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors bluebird bio
  • Most Recent Events

    • 08 Feb 2024 Status changed from active, no longer recruiting to completed.
    • 12 Dec 2023 Results (N=47, HGB-206 Group C, n=36; HGB-210, n=11)of pooled analysis (NCT02140554 and NCT04293185) assessing efficacy and safety from these studies, including the first data from adult and pediatric patients (age 12 to <18 years) in HGB-210, and HRQOL data from HGB-206, were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 09 Dec 2023 According to a bluebird bio media release, analysis (n=47) of data from the Phase 1/2 HGB-206 Group C and Phase 3 HGB-210 studies were highlighted in a press briefing at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition and will be presented in an oral presentation on Monday, December 11, 2023 at 4:30 p.m. Pacific Time.
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