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Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v14
  2. Primary completion date: Aug 31, 2024 to Dec 31, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    v13
  3. Study sites: 8 to 9v12
  4. Eligibility criteria expanded, about 6 wordsv11
  5. Primary completion date: Aug 31, 2023 to Aug 31, 2024
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    • Collaborators: 5 to 8
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 6 to 8v9
  2. Primary completion date: Dec 31, 2021 to Aug 31, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    v8
  3. Study sites: 4 to 6
    • Collaborators: 3 to 5
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary completion date: Dec 31, 2020 to Dec 31, 2021
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    • Eligibility criteria shortened, about 86 words
    • Site details revised at 1 of 4 sites
    v5
  6. Study sites: 3 to 4
    • Collaborators: 2 to 3
    v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2018 to Nov 1, 2018
    • Site details revised at 3 of 3 sites
    v3
  8. Start date: Oct 1, 2017 to May 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) 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 NCT03266640
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, Washington University School of Medicine, Indiana University, Children's Hospital Los Angeles
Conditions
(from sponsor)		 Cytomegalovirus Infections, Primary Immune Deficiency Disorder
Related terms Cytomegalovirus Infections, Primary Immunodeficiency Diseases
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov