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

Inclusion Criteria

• •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 of appropriate anti-viral 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 any study-related procedures.
• •Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) Age: 0.1 to 79.99 years Females of childbearing potential with a negative urine pregnancy test
• •Donor Eligibility Related donor available with a T-cell response to the CMV MACS® GMP PepTivator antigen(s).
• •a. Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party related allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with IgG positive to CMV and/or a T-cell response to the CMV MACS® GMP PepTivator .
• •AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).
• •AND Obtained informed consents by donor or donor legally authorized representative prior to donor collection.