Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment
This study is testing a new treatment called norovirus-specific T-cell (NST) therapy for people with long-lasting norovirus infections. This includes individuals who have had a hematopoietic stem cell transplant (HSCT), or who have primary immunodeficiency disorders (PID) or solid organ transplants (SOT) that weaken their immune system. The main goal is to see how safe NST therapy is at different doses. Researchers will also look for side effects like acute GvHD (graft-versus-host disease, a reaction where donor cells attack the patient's body) and other adverse events within 45 days of treatment. This study is currently unclear on its recruitment status and plans to enroll 48 participants aged 3 months to 80 years.
- Study design
- This is an open-label, Phase I study, meaning both you and the study team will know which treatment you are receiving. It aims to enroll 48 participants to test different doses of NST therapy.
- What's involved
- You would receive an infusion of NST therapy and then be monitored for 45 days for immediate side effects. You will also be monitored for infusion-related reactions and GvHD for 1 year after the first infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for infusion-related reactions and GvHD for 1 year following the first infusion.
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Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Michael Keller, MD · PRINCIPAL_INVESTIGATOR · CNH
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Incidence of acute GvHD (grade III-IV)Within 45 days of first NSTs infusion
Number of patients with acute GvHD grades III-IV
- Incidence of infusion related adverse events as per CTCAE common criteria guidelines.Within 45 days of first NSTs infusion
Number of patients with Grades 3-5 infusion-related adverse events
- Incidence of non-hematological adverse eventsWithin 45 days of first NSTs infusion
Number of patients with Grades 4-5 non-hematological adverse events related to the NST product within 45 days of the first infusion