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NCT05141058: TONI

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

Recruiting now Phase 1 Last updated 12 March 2026
What this trial tests

Phase 1 trial testing Coronavirus-specific T cell (CST) in SARS-CoV-2 Infection in 24 participants. Currently enrolling.

Timeline
19 October 2021
Primary endpoint
1 November 2028
15 December 2029

Quick facts

Lead sponsorChildren's National Research Institute
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposeprevention
Enrollment24
Start date19 October 2021
Primary completion1 November 2028
Estimated completion15 December 2029
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's National Research Institute

Who can join

Adults 2 to 80, any sex, with SARS-CoV-2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cellular therapies for the treatment and prevention of SARS-CoV-2 infection.
    Conway SR, Keller MD, Bollard CM. · · 2022 · cited 16× · PMID 35240679 · DOI 10.1182/blood.2021012249
  2. Pathogen-specific T Cells: Targeting Old Enemies and New Invaders in Transplantation and Beyond.
    Papadopoulou A, Alvanou M, Karavalakis G, Tzannou I, et al · · 2023 · cited 11× · PMID 36698615 · DOI 10.1097/hs9.0000000000000809
  3. Antigen-Specific T Cells and SARS-CoV-2 Infection: Current Approaches and Future Possibilities.
    Nova Z, Zemanek T, Botek N. · · 2022 · cited 1× · PMID 36499448 · DOI 10.3390/ijms232315122

Verify or expand the search:

Other recruiting trials for SARS-CoV-2 Infection

Currently open trials in the same condition.

Other Children's National Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05141058.

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