EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection

1. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary
   immunodeficiencies or post solid organ transplant with:
   • Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks ofviral therapy and/or
   • progressive clinical symptoms attributable to EBV, including biopsy proven colitis,ymphadenopathy, hepatomegaly, splenomegaly AND/OR
   • Medical intolerance to anti-viral therapies including:
   • intolerance to rituximab Consent: Written informed consent given (by patient or legalve) prior to any study-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 test2 Donor Eligibility 5.2.1 Related donor available with a T-cell response to the EBV MACS®GMP PepTivator antigen(s) causing the therapy-refractory EBV infection.. Third Party Related Allogeneic Donor: If original donor is not available or does nothave a T-cell response: third party related allogeneic donor (family donor > 1 HLA A, B, DRh to recipient) with IgG positive to EBV and/or a T-cell response at least to the viralACS® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1).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 CTL infusionPatient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusionPatient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusionPatient with poor performance status determined by Karnofsky (patients >16 years) or Lansky(patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinicalvestigating the treatment of refractory EBV infection Any medical condition whichuld compromise participation in the study according to the investigator's assessmentKnown HIV infection Female patient of childbearing age who is pregnant or breast-feeding orwilling to use an effective method of birth control during study treatment.Known hypersensitivity to iron dextran Patients unwilling or unable to comply with theunable to give informed consent.Known human anti-mouse antibodies