Actively Recruiting

Phase 1
Age: 3Months - 80Years
All Genders
NCT04691622

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Led by Children's National Research Institute · Updated on 2026-01-26

48

Participants Needed

3

Research Sites

345 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Who Can Participate

Age: 3Months - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 3 months to 80 years.
  • Recipient of prior allogeneic hematopoietic stem cell transplant or diagnosed with primary immunodeficiency disorder without HSCT or recipient of solid organ transplant.
  • Documented chronic norovirus infection with at least two positive stool tests over three months and related symptoms.
  • Steroid dosage must be tapered to less than 0.5 mg/kg/day prednisone or equivalent at least 7 days before infusion; enteral topical steroids allowed if previously used.
  • Stable donor chimerism within 30 days before infusion for HSCT recipients.
  • Stable graft function with no rejection evidence in the past 2 months for solid organ transplant recipients.
  • Karnofsky/Lansky score over 50.
  • Absolute neutrophil count at least 500/ul.
  • Hemoglobin level at least 7.0 g/dl (can be achieved with transfusion).
  • Platelet count at least 20 K/ul (can be achieved with transfusion).
  • Bilirubin less than twice the upper limit of normal.
  • AST less than three times the upper limit of normal.
  • Serum creatinine less than twice the upper limit normal or estimated GFR at least 30 ml/hr.
  • Pulse oximetry at least 90% on room air.
  • Negative pregnancy test for females of childbearing age.
  • Written informed consent or assent from participant, parent, or guardian.
  • Donors must meet FDA health criteria and complete infectious disease testing.
Not Eligible

You will not qualify if you...

  • Use of biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days before infusion.
  • Receipt of donor lymphocyte infusion, CAR T-cell infusion, or experimental cellular therapies within 28 days.
  • SCID patients who had alpha/beta TCR depleted HSCT in past 100 days.
  • Use of ruxolitinib or other JAK inhibitors within 7 days before infusion.
  • Uncontrolled or worsening infections other than norovirus.
  • Active gastrointestinal infections other than norovirus including certain parasitic, viral, or bacterial infections.
  • Active and uncontrolled relapse of malignancy.
  • Failure of primary engraftment or secondary graft failure.
  • Symptomatic gastrointestinal conditions other than norovirus, such as active inflammatory bowel disease or GVHD grades 2 to 4.
  • Receipt of small bowel transplant.
  • Use of checkpoint inhibitors within 3 months before infusion.
  • Recent intensification or alteration of immunosuppression in solid organ transplant recipients.
  • Use of enteral immunoglobulin, nitazoxanide, or experimental therapies for norovirus within 28 days.
  • Co-enrollment in other trials except natural history or observational studies without approval.
  • Donors with physical or psychological risks precluding donation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

3

National Institutes of Health (NIH)

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Michael Keller, MD

CONTACT

F

Fahmida Hoq, MBBS, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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