RecruitingPhase 1NCT04691622

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts


Sponsor

Children's National Research Institute

Enrollment

48 participants

Start Date

Mar 17, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 MonthsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adoptive T lymphocyte (immune cell) infusions — specifically norovirus-specific T cells (NST) — can treat chronic norovirus infection in immunocompromised patients. Norovirus is a common stomach bug that causes vomiting and diarrhea; in healthy people it resolves quickly, but in people with weakened immune systems (such as after a stem cell transplant or organ transplant), it can become a chronic, debilitating infection. This therapy infuses specially selected immune cells that specifically target norovirus. You may be eligible if: - You are between 3 months and 80 years old - You are immunocompromised due to a prior stem cell transplant, a primary immune deficiency, or a solid organ transplant - You have chronic norovirus infection, confirmed by two or more positive stool tests spanning at least 3 months, with ongoing symptoms - You have adequate blood counts and organ function - If you are on steroids for GVHD or other reasons, you are on a dose of less than 0.5 mg/kg/day of prednisone or equivalent You may NOT be eligible if: - You have received certain immune-suppressing antibody therapies (e.g., ATG, alemtuzumab, tocilizumab) within 28 days of the infusion - You have another uncontrolled active infection besides norovirus - You have other active gastrointestinal infections that could explain your symptoms - You have active GVHD of grades 2–4 or active relapse of a malignancy - You have received a small bowel transplant Talk to your transplant or immunology team about whether your norovirus infection has been formally confirmed with serial stool tests and whether your immune status is appropriate for this cell therapy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNorovirus -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.


Locations(3)

Children's National Hospital

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

Johns Hopkins University

Baltimore, Maryland, United States

National Institutes of Health (NIH)

Bethesda, Maryland, United States

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NCT04691622


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