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Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

NCT04691622 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-01-26

No results posted yet for this 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.

Conditions

  • Viral Infection
  • Hematopoietic Stem Cell Transplantation (HSCT)
  • Primary Immunodeficiency Disorders (PID)

Interventions

BIOLOGICAL

Norovirus -specific T-cell (NST) therapy

Arm A: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion. Arm B: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Michael Keller, MD · CNH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2028-08-30
Completion
2028-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04691622 on ClinicalTrials.gov