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T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation

Study acronym: NATS
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Mar 2026 → Nov 2026
See other at-risk trials from Children's National Research Institute

Record History

  1. Primary completion pushed from Mar 2026 to Nov 2026 Completion pushed from Nov 2026 to Dec 2026v16 Show 1 more changeShow less
    • Completion pushed from Nov 2026 to Dec 2026
  2. Re-verified, no change to tracked fieldsv15
  3. Primary completion date: Oct 2024 to Mar 2026 Completion date: Nov 2024 to Nov 2026v14 Show 1 more changeShow less
    • Completion date: Nov 2024 to Nov 2026
  4. Primary completion date: Oct 2023 to Oct 2024 Completion date: Nov 2023 to Nov 2024v13 Show 1 more changeShow less
    • Completion date: Nov 2023 to Nov 2024
  5. Primary completion date: Jul 2022 to Oct 2023 Trial status: Recruiting to Active, Not Recruiting · Completion date: Aug 2023 to Nov 2023 · Site details revisedv12 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Aug 2023 to Nov 2023
    • Site details revised
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date: Jul 2020 to Jul 2022 Completion date: Aug 2021 to Aug 2023v10 Show 1 more changeShow less
    • Completion date: Aug 2021 to Aug 2023
  3. Eligibility criteria shortened, about 137 wordsv9 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv8
  5. Secondary endpoints: details revised at 2 of 2 entriesv7
  6. Re-verified, no change to tracked fieldsv6
  7. Eligibility criteria expanded, about 202 wordsv5 See this version in full on ClinicalTrials.gov ↗
  8. Start date changed from estimate of Aug 2017 to Feb 15, 2017v4
  9. Start date: Jul 2017 to Aug 2017v3
  10. Primary endpoints: 1 to 2 Secondary endpoints revised (2)v2 Show 1 more changeShow less
    • Secondary endpoints revised (2)

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors. In this trial, we will utilize a rapid generation protocol for broad spectrum multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3, or with PCR/culture confirmed active infection(s) of EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). These cells will be derived from HSCT donors, and the study agent will be assessed at each dose for evidence of dose-limiting toxicities (DLT). This study will have two arms: Arm A will include patients who receive prophylactic treatment, and Arm B will include patients who receive VSTs for one or more active infections with targeted viruses. Determination of the study arm will be determined by the patient's clinical status. Study arms will each be analyzed for safety endpoints and secondary endpoints.
Trial Details
NCT Number NCT03180216
Lead Sponsor Children's National Research Institute
Conditions Viral Infections, Bone Marrow Transplant Infection
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov