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NCT04691622 · ClinicalTrials.gov registry record · Phase 1

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

A Phase 1 study of Viral Infection and Hematopoietic Stem Cell Transplantation (HSCT), sponsored by Children's National Research Institute.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
3
Study locations

NCT04691622: Recruiting Phase 1 study of Viral Infection and Hematopoietic Stem Cell Transplantation (HSCT), sponsored by Children's National Research Institute.

NCT04691622 is a Phase 1 study of Viral Infection and Hematopoietic Stem Cell Transplantation (HSCT) that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 48 participants, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (79% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04691622, a Phase 1 study of Viral Infection and Hematopoietic Stem Cell Transplantation (HSCT), is actively recruiting participants, sponsored by Children's National Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
3
Study locations

Study Summary

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.

Primary Outcome

Number of patients with acute GvHD grades III-IV

Interventions

  • BIOLOGICAL Norovirus -specific T-cell (NST) therapy

Study Locations (3)

Maryland

  • Johns Hopkins University - Baltimore
  • National Institutes of Health (NIH) - Bethesda

District of Columbia

  • Children's National Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2022-03-17
Est. Completion 2028-10-30
Phase Phase 1

What NCT04691622 shows while recruiting

NCT04691622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (79% lower).

The record links to 3 conditions, with Viral Infection appearing as the primary indexed condition, and to 1 intervention - of which Norovirus -specific T-cell (NST) therapy is the first listed.

NCT04691622 reports a single indexed study location in Maryland, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT04691622 about?

NCT04691622 is a clinical study titled "Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts". 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 Tran...

What is the current status of trial NCT04691622?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2022-03-17. Estimated completion is 2028-10-30.

What conditions does trial NCT04691622 study?

This clinical trial studies the following conditions: Viral Infection, Hematopoietic Stem Cell Transplantation (HSCT), Primary Immunodeficiency Disorders (PID).

What interventions are being tested in trial NCT04691622?

The interventions under investigation include: Norovirus -specific T-cell (NST) therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT04691622?

This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04691622 being conducted?

This trial has 3 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Viral Infection

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04691622's enrollment target sits among peer trials

48 7th of 11 higher than 5 of 11 other Viral Infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Viral Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04691622, the US trial registry maintained by the National Library of Medicine. NCT04691622 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.