Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells

Exclusion Criteria

• •1. Patient with acute GVHD \> grade 2 or active moderate or severe chronic GVHD at time of T-cell transfer
• •2. Patient receiving steroids (\>1.0 mg/kg body weight (BW) prednisone equivalent) at the time of T-cell transfer
• •3. Patient received allogeneic HSCT less than 28 days prior to T-cell transfer
• •4. Patient treated with donor lymphocyte infusion (DLI) within 28 days prior to T-cell transfer
• •5. Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive monoclonal antibodies within 28 days.
• •6. Patient with organ dysfunction or failure as determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% (Appendix 5)
• •7. Patients with CMV retinitis
• •8. Concomitant enrollment in another clinical trial with endpoints interfering with this study
• •9. Any medical condition which could compromise participation in the study according to the investigator's assessment
• •10. Known HIV infection
• •11. 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.
• •12. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
• •Donor Eligibility:
• •The original donor will be the first choice as source of T cells. If the original donor is not available for donation (such as NMDP donor, cord blood unit, or related donor not available) of peripheral mononuclear cells or does not meet all donor eligibility criteria (including donor selection criteria based on University of Wisconsin - Madison Standard Operating Procedures for the selection of allogeneic donors), alternative related donors will be selected, with preference for those who have full HLA matching in 6/6 loci over those with partial HLA matching (≥ 3/6 HLA loci).
• •1. 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.
• •2. 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).
• •3. Donors must be CMV IgG seropositive.
• •4. Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator Peptide Pools of CMV pp65 before undergoing leukapheresis.
• •5. 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.