Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

1. Patients with refractory CMV infection post allogeneic HSCT, with primary
   immunodeficiencies or post solid organ transplant with either
   • Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks ofviral therapy AND/OR
   • Medical intolerance to anti-viral therapies including:
   • ANC < 500/mm2 secondary to ganciclovir
     • 2 renal toxicity with foscarnet And/or
   • known resistance to ganciclovir and/or foscarnet

        Consent: Written informed consent given (by patient or legal representative) prior to anyudy-related procedures.Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) Age: 0.1 to 30.99 yearsFemales of childbearing potential with a negative urine pregnancy testDonor Eligibility Related donor available with a T-cell response to the CMV MACS® GMPPepTivator antigen(s).. Third Party Allogeneic Donor: If original donor is not available or does not have aT-cell response: third party related allogeneic donor (family donor > 1 HLA A, B, DR match) with IgG positive to CMV and/or a T-cell response to the CMV MACS® GMPPepTivator .AND Allogeneic donor disease screening is complete similar to hematopoietic stem celldonors (Appendix 1).AND Obtained informed consents by donor or donor legally authorized representative prior todonor collection.3 Patient exclusion criteria:A patient meeting any of the following criteria is not eligible for the present study:Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of CMV CTL infusionPatient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CMV CTLusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMVCTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonalbodies within 30 days Patient with poor performance status determined by Karnofsky(patients >16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitanther experimental clinical trial investigating the treatment of refractoryCMV infection.Any medical condition which could compromise participation in the study according to thevestigator's assessment Known HIV infection Female patient of childbearing age who isgnant or breast-feeding or not willing to use an effective method of birth controlduring study treatment.Known hypersensitivity to iron dextran Patients unwilling or unable to comply with theunable to give informed consent.Known human anti-mouse antibodies