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Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v15
  2. Notable Primary completion date: Aug 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v14
  3. Minor Study sites: 9 to 10v13
  4. Minor Eligibility criteria revisedv12
  5. Notable Primary completion date: Aug 31, 2023 to Aug 31, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Collaborators: 6 to 9
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Study sites: 7 to 9v10
  2. Notable Primary completion date: Dec 31, 2021 to Aug 31, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    v9
  3. Minor Study sites: 4 to 7
    • Collaborators: 3 to 6
    v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary completion date: Dec 31, 2020 to Dec 31, 2021
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Eligibility criteria shortened, about 84 words
    • Site details revised at 1 of 4 sites
    v6
  6. Minor Study sites: 3 to 4
    • Collaborators: 2 to 3
    v5
  7. Minor Study sites: 2 to 3v4
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2018 to Nov 1, 2018
    • Site details revised at 2 of 2 sites
    v3
  9. Notable Start date: Oct 1, 2017 to May 1, 2018v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
Trial Details
NCT Number NCT03266627
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, University of Colorado, Denver, Indiana University, Washington University School of Medicine, University of California, Los Angeles
Conditions
(from sponsor)
Adenovirus, Primary Immune Deficiency Disorder
Related terms Adenoviridae Infections, Primary Immunodeficiency Diseases
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov