Phase I Study of Norovirus-Specific T-Cell Therapy for Chronic Norovirus Infection in Immunocompromised Patients After Stem Cell or Organ Transplant or With Primary Immunodeficiency

What this Trial Is About

Researchers are evaluating the safety of norovirus-specific T-cell NST therapy for people with chronic norovirus infection who have weakened immune systems due to prior hematopoietic stem cell transplantation HSCT, primary immunodeficiency disorders PID, or solid organ transplantation SOT. This Phase I, open-label study aims to assess how well NST therapy is tolerated in these immunocompromised participants, focusing especially on safety outcomes like infusion reactions and graft-versus-host disease GVHD. The study includes two treatment groups Arm A participants who receive NSTs derived from their HSCT donor, and Arm B participants who receive partially matched NSTs from a donor bank. Both arms will test three dose levels of NST therapy 1x107m2, 2x107m2, and 4x107m2. After infusion, participants undergo a 45-day period of close monitoring for immediate side effects. Participants in Arm B include those with PID who have not undergone HSCT, those post-HSCT without available donor NSTs, or SOT recipients. Participants will be followed for one year after their first infusion to monitor for infusion-related reactions, GVHD, and norovirus shedding in stool. Gastrointestinal and general symptoms will be regularly assessed by clinicians and participants. The study also examines immune recovery, norovirus genetics, and gut microbiome changes. Safety and antiviral effects will be carefully evaluated, with long-term follow-up to understand the therapys impact and tolerability.

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts