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A Study Evaluating Gene Therapy With BB305 Lentiviral Vector in Sickle Cell Disease

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v20
  2. Site details revised at 1 of 9 sitesv19
  3. Primary completion date: Oct 2026 to May 2027
    • Study completion date: Apr 2027 to Nov 2027
    v18
  4. Study sites: 8 to 9v17
  5. Primary completion date: Feb 2025 to Oct 2026
    • Study sites: 9 to 8
    • Study completion date: Sep 2025 to Apr 2027
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary endpoint revised
    • Eligibility criteria shortened, about 57 words
    • Secondary endpoints revised (34)
    • Site details revised at 1 of 9 sites
    v15
  2. Study sites: 8 to 9v14
  3. Study sites: 7 to 8v13
  4. Study sites: 6 to 7v12
  5. Re-verified, no change to tracked fieldsv11
  6. Primary completion date: Jul 2024 to Feb 2025
    • Study completion date: Jan 2025 to Sep 2025
    • Site details revised at 1 of 6 sites
    v10
  7. Site details revised at 2 of 6 sitesv9
  8. Trial status: Active, Not Recruiting to Recruitingv8 Show 7 more changesShow less
    • Primary completion date: Nov 2023 to Jul 2024
    • Primary endpoint revised
    • Study completion date: Nov 2023 to Jan 2025
    • Interventions: LentiGlobin BB305 Drug Product for SCD (Genetic) to bb1111 (Genetic)
    • Eligibility criteria expanded, about 96 words
    • Secondary endpoints: 44 to 34
    • Site details revised at 6 of 6 sites
  9. Trial status: Suspended to Active, Not Recruitingv7
  10. Trial status: Recruiting to Suspended Sponsor's reason: Study suspended due to the occurrence of a SUSAR. During suspension, no enrollment, new mobilization, cell collection, conditioning or…
    • Site details revised at 6 of 6 sites
    v6
  11. Study sites: 5 to 6v5
  12. Site details revised at 1 of 5 sitesv4
  13. Study sites: 4 to 5v3
  14. Study sites: 2 to 4
    • Secondary endpoints revised (44)
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 non-randomized, open-label, multi-site, single-dose, Phase 3 study in approximately 35 adults and pediatric subjects ≥2 and ≤50 years of age with sickle cell disease (SCD). The study will evaluate hematopoietic stem cell (HSC) transplantation (HSCT) using bb1111 (also known as LentiGlobin BB305 Drug Product for SCD).
Trial Details
NCT Number NCT04293185
Lead Sponsor Genetix Biotherapeutics Inc.
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov