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Safety and Efficacy of Gene Modified Autologous Hematopoietic Stem Cells to Treat Transfusion-dependent Beta-thalassemia

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 14, 2024 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Start date changed from estimate of Mar 2023 to Sep 15, 2023
    • Primary endpoints: 2 to 1
    • Study sites: 0 to 1
    • Eligibility criteria revised
    • Secondary endpoints: 10 to 14
    • Study description revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will be intented to evaluate the safety, tolerability, and engraftment efficacy after myeloablative preconditioning and transplantation of autologous CD34+ hematopoietic stem cells transduced with a lentiviral vector encoding the human βA-T87Q-globin gene in patients with transfusion-dependent (TDT) β-thalassemia.
Trial Details
NCT Number NCT05773729
Lead Sponsor Shanghai BDgene Co., Ltd.
Collaborators: Shanghai Children's Medical Center
Conditions
(from sponsor)		 β-thalassemia
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov