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Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study sites: 8 to 7
    • Study completion date: Jun 30, 2025 to Jun 30, 2027
    v8
  2. Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Jun 30, 2024 to Jun 30, 2025
    • Site contacts updated at 1 of 8 sites
    v7
  3. Eligibility criteria revisedv6
  4. Study sites: 6 to 8v5
  5. Study sites: 4 to 6
    • Collaborators: 3 to 5
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2020 to Jul 1, 2020
    • Study sites: 3 to 4
    • Eligibility criteria expanded, about 4 words
    v3
  2. Start date: Jan 1, 2020 to Apr 1, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
Trial Details
NCT Number NCT04197596
Lead Sponsor New York Medical College
Collaborators: Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco
Conditions
(from sponsor)		 Viral Infection, Primary Immune Deficiency Disorder
Related terms Primary Immunodeficiency Diseases, Virus Diseases
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov