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NCT05141058: TONI
T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients
Phase 1 trial testing Coronavirus-specific T cell (CST) in SARS-CoV-2 Infection in 24 participants. Currently enrolling.
1 November 2028
Quick facts
| Lead sponsor | Children's National Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 24 |
| Start date | 19 October 2021 |
| Primary completion | 1 November 2028 |
| Estimated completion | 15 December 2029 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Coronavirus-specific T cell (CST) — full drug profile →
Conditions studied
- SARS-CoV-2 Infection — all drugs for SARS-CoV-2 Infection →
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):
-
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 -
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 -
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:
- PubMed search for NCT05141058
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Children's National Research Institute trials
Trials by the same sponsor.
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- NCT06618027 — Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes · NA · recruiting
- NCT06770010 — Advancing Feasibility and Acceptability of Digital Cognitive Rehabilitation in Sickle Cell Disease · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05141058 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's National Research Institute
- Last refreshed: 12 March 2026
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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