Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts (NCT04691622) | Clinical Trial Compass
RecruitingPhase 1
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
United States48 participantsStarted 2022-03-17
Plain-language 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.
Who can participate
Age range3 Months – 80 Years
SexALL
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Inclusion criteria
✓. Participants must meet one of the following criteria:
✓. 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.
✓. Documentation of chronic norovirus infection:
✓. 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.
✓. For participants who have undergone HSCT, participants must have stable donor chimerism within the 30 days prior to NST infusion.
✓. For recipients of solid organ transplants, participants must have stable graft function on maintenance immunosuppression, without evidence of rejection in the past 2 months prior to infusion, as defined by:
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of acute GvHD (grade III-IV)
Timeframe: Within 45 days of first NSTs infusion
2
Incidence of infusion related adverse events as per CTCAE common criteria guidelines.
✕. 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.
✕. Participants with uncontrolled or progressing infections other than norovirus. Uncontrolled infections are defined as bacterial, fungal, or non-targeted viral infections with either clinical signs of worsening despite standard therapy, or chronic gastrointestinal symptoms that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
✕. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to NST infusion and or no chronic gastrointestinal symptoms associated with this bacterial infection.
✕. For fungal infections, participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to NST infusion.
✕. Participants must not have other active gastrointestinal infections to which symptoms may be attributable, including parasitic infections (cryptosporidium, giardiasis), viral infections aside from norovirus (CMV colitis, rotavirus, adenovirus), or bacterial infections with C. difficile, Yersinia, Campylobacter, Salmonella, Shigella, or enteroinvasive or enterotoxigenic E. coli.