Experimental T-Cell therapy targets CMV in transplant patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration * Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met) * Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND * Patients must have ONE OF THE NEXT FOUR 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. * Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 * Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment. * Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document. Exclusion Criteria: * Pregnant or breastfeeding women are excluded from this study. * Patients with opportunistic viral infections other than CMV. * Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\>0.5 mg/kg/day prednisone or its equivalent) as treatment * Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells. * Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion. Donor eligibility * Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this). * Must have evidence of a serologic response (i.e. be seropositive) against CMV. * Age ≥ 18 years * Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program * Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood