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Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Oct 1, 2026 to Jan 1, 2028
    • Study completion date: Oct 1, 2028 to Jan 1, 2028
    • Site contacts updated at 3 of 4 sites
    v20
  2. Study sites: 5 to 4v19
  3. Trial status: Active, Not Recruiting to Recruitingv18 Show 4 more changesShow less
    • Enrollment target: 10 to 12
    • Study completion date: Oct 1, 2027 to Oct 1, 2028
    • Study description revised
    • Site details revised at 5 of 5 sites
  4. Primary completion date: Oct 1, 2025 to Oct 1, 2026v17 Show 5 more changesShow less
    • Start date: Jan 19, 2018 to Feb 26, 2018
    • Enrollment target: 12 to 10
    • Study sites: 6 to 5
    • Study completion date: Oct 1, 2025 to Oct 1, 2027
    • Study description expanded, about 8 words
  5. Enrollment target: 10 to 12v16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v15
  2. Primary and study completion dates: Apr 1, 2025 to Oct 1, 2025v14
  3. Primary completion date: Jan 1, 2023 to Apr 1, 2025
    • Study sites: 5 to 6
    • Study completion date: Jan 1, 2024 to Apr 1, 2025
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary completion date: Jan 1, 2022 to Jan 1, 2023v11
  6. 2 versions Re-verified since Jan 6, 2021, no change to tracked fieldsv9-v10
  7. Study sites: 3 to 5
    • Collaborators shortened, about 5 words
    v8
  8. Primary completion date: Jan 1, 2021 to Jan 1, 2022
    • Study completion date: Jan 1, 2023 to Jan 1, 2024
    v7
  9. Study sites: 2 to 3
    • Eligibility criteria expanded, about 3 words
    v6
  10. Site details revised at 1 of 2 sitesv5
  11. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Nov 1, 2020 to Jan 1, 2021
    • Study completion date: Nov 1, 2022 to Jan 1, 2023
    • Start date changed from estimate of Jan 1, 2018 to Jan 19, 2018
    • Site details revised at 2 of 2 sites
  12. Study sites: 1 to 2v3
  13. Start date: Nov 1, 2017 to Jan 1, 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase I/II open label multi-center study in which patients will receive low dose targeted busulfan followed by infusion of autologous CD34+ selected bone marrow or mobilized peripheral blood cells transduced with the G2SCID vector. Subjects will be enrolled over 3 years and be followed for 2 years post-infusion on this protocol, then followed long-term on a separate long-term follow-up protocol. Enrollment of subjects will be agreed upon by representatives of both sites. Data will be collected uniformly from both sites through an electronic capture system and key laboratory studies will be centralized. Harvest, cellular manufacturing and infusion will occur at each site using the same SOPs. Key aspects of cellular product characterization will be centralized
Trial Details
NCT Number NCT03311503
Lead Sponsor David Williams
Conditions
(from sponsor)		 Severe Combined Immunodeficiency, X Linked, Gene Therapy
Related terms X-Linked Combined Immunodeficiency Diseases
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov