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A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia [TDT]

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Primary endpoints revised (3)
    • Secondary endpoints revised (9)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a single-arm, open label, single-dose study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CD34+ Human Hematopoietic Stem Cells that was transduced with LentiRed Lentivrial vector.
Trial Details
NCT Number NCT05762510
Lead Sponsor First Affiliated Hospital of Guangxi Medical University
Collaborators: Genmedicn Biopharma Ltd.
Conditions
(from sponsor)		 Transfusion Dependent Beta-Thalassemia
Related terms beta-Thalassemia
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov