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Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections

Study acronym: ADV-VSTS
StatusRecruiting
PhasePhase 1/2
Started
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Record status
This record was last updated May 13, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 1, 2024 to Oct 1, 2026
    • Study completion date: Oct 1, 2024 to Oct 1, 2027
    v6
  2. Primary completion date: Oct 1, 2023 to Oct 1, 2024v5
  3. Primary completion date: Oct 1, 2022 to Oct 1, 2023
    • Study completion date: Oct 1, 2023 to Oct 1, 2024
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  5. Primary completion date: Apr 1, 2022 to Oct 1, 2022
    • Start date: Apr 1, 2021 to Oct 1, 2021
    • Study completion date: Apr 1, 2023 to Oct 1, 2023
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
Trial Details
NCT Number NCT04722029
Lead Sponsor Nationwide Children's Hospital
Conditions
(from sponsor)		 Adenovirus Infection
Related terms Adenoviridae Infections
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov