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T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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

Record History

  1. Primary completion date: Nov 1, 2025 to Nov 1, 2028 Completion date: Dec 15, 2027 to Dec 15, 2029v5 Show 1 more changeShow less
    • Completion date: Dec 15, 2027 to Dec 15, 2029
  2. Eligibility criteria shortened, about 16 words Study description expanded, about 110 words · Site contacts updated at 1 of 2 sites · Study arms: 2 to 3v4 Show 3 more changesShow less
    • Study description expanded, about 110 words
    • Site contacts updated at 1 of 2 sites
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 10 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 1 to 2v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open label, phase I dose-escalation study to evaluate the safety of coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT). Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and \<4 months after HSCT). In this dose escalation trial, three doses (1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for adult (≥18 years of age and \<80 years) HSCT recipients (Arm A) and two arms for pediatric (≥12 years of age and \<18 years; ≥2 years and \<12 years) HSCT recipients (Arm B and Arm C, respectively), and defined dose escalations in each study arm. The study agent will be assessed for safety (stopping rules defined) and antiviral activity.
Trial Details
NCT Number NCT05141058
Lead Sponsor Children's National Research Institute
Conditions SARS-CoV-2 Infection
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov