Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-80
SponsorChildren's National Research Institute

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Norovirus -specific T-cell (NST) therapy

Treatment groups

48 Participants
are divided into 1 treatment group