A Type of Immunotherapy (CMV Specific T Cells) in Treating CMV Infection in Pediatric and Adult Immunocompromised Patients or Stem Cell Transplant Recipients

Inclusion Criteria

• Adult or pediatric patient suffering from CMV reactivation/infections following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy) * CMV reactivation/viremia defined as positive (> 500 copies/ml) CMV quantitative (q)PCR and/or * Presence of symptoms secondary to CMV infection or evidence of invasive CMV infection (e.g. pneumonitis, colitis)
• Patients must have ONE OF THE FOLLOWING CRITERIA: * Absence of an improvement of viral load after >= 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold), or * New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet, or * Known resistance to ganciclovir and/or foscarnet based on molecular testing
• Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time of T-cell transfer
• Written informed consent given by patient or legal representative
• Minimum patient age 1 month
• Minimum weight 7 lbs
• Female patients of childbearing age with negative pregnancy tests
• Patient Karnofsky/Lansky performance status > 30%
• Donor eligible based on Foundation for the Accreditation of Cellular Therapy (FACT) infectious screening requirements
• DONOR: All donors must be >= 18 years old, available, CMV IgG positive, eligible and capable of undergoing a single standard 2 blood volume leukapheresis. If original HSCT donor is not available, CMV IgG negative or ineligible, a CMV IgG positive fully matched or haploidentical family donor will be used
• DONOR: Related donors must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this)
• DONOR: Donors must be CMV IgG seropositive
• DONOR: Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator Peptide Pools of CMV pp65 before undergoing leukapheresis
• DONOR: Donor must meet the criteria for donor selection defined in the Standard Operating Procedures of the University of Wisconsin Hospitals and Clinics Stem Cell Transplant Program and in FACT standards

Exclusion Criteria

• Patient with acute graft versus host disease (GVHD) > grade 2 or active moderate or severe chronic GVHD at time of T-cell transfer
• Patient receiving steroids (> 1.0 mg/kg body weight [BW] prednisone equivalent) at the time of screening
• Patient received allogeneic HSCT less than 28 days prior to T-cell transfer
• Patient treated with donor lymphocyte infusion (DLI) within 28 days prior to T-cell transfer
• Patient treated with thymoglobulin (ATG), alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days
• Patient with organ dysfunction or failure as determined by Karnofsky (patients > 16 years) or Lansky (patients =< 16 years) score =< 30%
• Patients with CMV retinitis
• Concomitant enrollment in another clinical trial with endpoints interfering with this study
• Any medical condition which could compromise participation in the study according to the investigator’s assessment
• Known human immunodeficiency virus (HIV) infection
• Female patient who is pregnant or breast-feeding, or adult of reproductive potential not willing to use an effective method of birth control during study treatment. * Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
• Patients unwilling or unable to comply with the protocol or unable to give informed consent. Additionally, patients will not be selected from vulnerable populations including those lacking consent capacity, constituting prisoners and/or unable to read/review consent materials (e.g., non-English speaking)
• DONOR: If donor fails to meet any of the inclusion criteria, they will not be eligible to participate in the study. Donors will not be selected from vulnerable populations including those lacking consent capacity, identified as pregnant, constituting prisoners, and/or unable to read/review consent materials (e.g., non-English speaking)