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.
Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood OR
Primary immunodeficiency disorder (as defined by clinical and laboratory evaluations)81 and have not undergone HSCT, OR
Recipients of solid organ transplant.
Participants receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to <0.5 mg/kg/day of prednisone (or equivalent) a minimum of 7 days prior to infusion.
Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to NST infusion, including ATG, Alemtuzumab, Basiliximab, Tocilizumab, Brentuximab, or other medications under this category as determined by the investigators.
Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to NST infusion.
Participants with SCID who have undergone α/β TCR depleted HSCT within the past 100 days post-transplant.
Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to NST infusion.
Single group
Norovirus -specific T-cell (NST) therapy
Biological/VaccineArm 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.
Incidence of acute GvHD (grade III-IV)
Number of patients with acute GvHD grades III-IV
Incidence of infusion related adverse events as per CTCAE common criteria guidelines.
Number of patients with Grades 3-5 infusion-related adverse events
Incidence of non-hematological adverse events
Number of patients with Grades 4-5 non-hematological adverse events related to the NST product within 45 days of the first infusion
Antiviral activity
Antiviral activity will determined by measurements in viral loads by RT-PCR from stool samples in comparison to the mean baseline viral load.
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