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Safety and Efficacy Evaluation of BRL-101 in Subjects With Transfusion-Dependent β-Thalassemia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 20, 2026 → Oct 20, 2026
See other at-risk trials from Bioray Laboratories

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Enrolling by Invitation → Active, Not Recruitingv6 Show 4 more changesShow less
    • Primary completion pushed from Aug 20, 2026 to Oct 20, 2026
    • Trial sites expanded: 4 → 7 locations
    • Start date: Nov 1, 2022 to Nov 2, 2022
    • Collaborators: 4 to 7
  2. Phase: Phase 1 to Phase 1/2
    • Enrollment target: 9 to 39
    • Primary completion date: Aug 4, 2025 to Aug 20, 2026
    • Study completion date: Sep 10, 2026 to Jul 10, 2027
    v5
  3. Study sites revised (4)
    • Collaborators expanded, about 23 words
    v4
  4. Primary endpoints: 5 to 3
    • Trial status: Recruiting to Enrolling by Invitation
    • Study description expanded, about 96 words
    • Site details revised at 4 of 4 sites
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 14, 2022 to Nov 1, 2022
    • Site details revised at 4 of 4 sites
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Bioray Laboratories
10 trials monitored
See 1 trial at risk
Thalassemia
161 trials monitored
See 6 trials at risk
This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in subjects with Transfusion-Dependent β-Thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)
Trial Details
NCT Number NCT05577312
Lead Sponsor Bioray Laboratories
Collaborators: First Affiliated Hospital of Guangxi Medical University, Xiangya Hospital of Central South University, Chinese Academy of Medical Sciences, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, Shenzhen Children's Hospital
Conditions
(from sponsor)		 Beta-Thalassemia
Related terms beta-Thalassemia
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov