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NCT04691622: ATLANTIC

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Recruiting now Phase 1 Last updated 26 January 2026
What this trial tests

Phase 1 trial testing Norovirus -specific T-cell (NST) therapy in Viral Infection in 48 participants. Currently enrolling.

Timeline
17 March 2022
Primary endpoint
30 August 2028
30 October 2028

Quick facts

Lead sponsorChildren's National Research Institute
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment48
Start date17 March 2022
Primary completion30 August 2028
Estimated completion30 October 2028
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's National Research Institute

Who can join

Adults 3 Months to 80, any sex, with Viral Infection or Hematopoietic Stem Cell Transplantation (HSCT). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.

Publications & conference data

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

  1. Standardization of an antiviral pipeline for human norovirus in human intestinal enteroids demonstrates nitazoxanide has no to weak antiviral activity.
    Lewis MA, Cortés-Penfield NW, Ettayebi K, Patil K, et al · · 2023 · cited 26× · PMID 37787556 · DOI 10.1128/aac.00636-23
  2. Reconstitution of Norovirus-Specific T-Cell Responses Following Hematopoietic Stem Cell Transplantation in Patients With Inborn Errors of Immunity and Chronic Norovirus Infection.
    Durkee-Shock J, Cohen A, Maghzian N, Pezzella G, et al · · 2025 · cited 5× · PMID 39140311 · DOI 10.1093/infdis/jiae398
  3. Harnessing virus-specific T cells: expanding therapeutic strategies across diverse populations.
    Djassemi N, Hanisch B, Motta C, Maghzian N, et al · · 2025 · cited 2× · PMID 40864193 · DOI 10.1182/bloodadvances.2024013727

Verify or expand the search:

Other recruiting trials for Viral 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

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