A Form of Immunotherapy (Adoptive T Cell Therapy) in Treating Patients with Adenovirus Infection after Stem Cell Transplant

Inclusion Criteria

• Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration
• Patients must have evidence of documented HAdV infection/reactivation. Patients may be: * Symptomatic with any detectable viral load OR * Asymptomatic with viral load that is: > 1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens (bronchoalveolar lavage [BAL], cerebrospinal fluid [CSF] etc).
• Patients must have poor response and/or contraindication to therapy: * Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after >= 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR * New, persistent and/or worsening HAdV-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, cidofovir or foscarnet
• Age 3 months or older
• Performance score * Eastern Cooperative Oncology Group performance status (ECOG PS) =< 3 (for adults) * Karnofsky (for pediatric patients 16 years or older) or Lansky (for pediatric patients < 16 years) performance score >= 50
• The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, 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 who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document. Subjects who are between the ages of 7 to 13 will be given an information sheet that explains the study to them. The information sheet may be used for study participants between the ages of 14-17 if it would better inform the child about the nature and procedures of the study
• DONOR ELIGIBILITY:
• Related donor of T cells must be at least partially human leukocyte antigen (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 HAdV
• Age >= 18 years
• Must meet the criteria for donor selection defined in the Standard Operating Procedures (SOP) of University Hospitals (UH) Seidman Cancer Center Stem Cell Transplant Program (SOP B6.00 Allogeneic Donor Selection, Evaluation, and Management)
• Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood

Exclusion Criteria

• Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial
• Patients with opportunistic viral infections other than HAdV
• Patients with active, grade II-IV, acute graft versus 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