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Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Study acronym: ATLANTIC
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Study sites: 2 to 3 Eligibility criteria expanded, about 260 words · Study description expanded, about 5 wordsv9 Show 2 more changesShow less
    • Eligibility criteria expanded, about 260 words
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Aug 30, 2025 to Aug 30, 2028 Completion date: Oct 30, 2026 to Oct 30, 2028v8 Show 1 more changeShow less
    • Completion date: Oct 30, 2026 to Oct 30, 2028
  4. 2 versions Re-verified since Feb 2, 2023, no change to tracked fieldsv6-v7
  5. Start date: Oct 26, 2020 to Mar 17, 2022 Primary completion date: Aug 2025 to Aug 30, 2025 · Completion date: Oct 2026 to Oct 30, 2026v5 Show 2 more changesShow less
    • Primary completion date: Aug 2025 to Aug 30, 2025
    • Completion date: Oct 2026 to Oct 30, 2026
Show 3 earlier versionsHide 3 earlier versions
  1. Start date changed from estimate of Oct 21, 2021 to Oct 26, 2020v4
  2. Start date: Oct 24, 2020 to Oct 21, 2021v3
  3. Study description revisedv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.
Trial Details
NCT Number NCT04691622
Lead Sponsor Children's National Research Institute
Conditions Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT), Primary Immunodeficiency Disorders (PID)
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov