Overview

CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.

Funding Source: FDA OOPD

Eligibility

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.
        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 infusion
        Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CMV CTL
        infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV
        CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal
        antibodies within 30 days Patient with poor performance status determined by Karnofsky
        (patients >16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant
        enrollment in another experimental clinical trial investigating the treatment of refractory
        CMV infection.
        Any medical condition which could compromise participation in the study according to the
        investigator's assessment Known HIV infection Female patient of childbearing age who is
        pregnant or breast-feeding or not willing to use an effective method of birth control
        during study treatment.
        Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the
        protocol or unable to give informed consent.
        Known human anti-mouse antibodies CMV retinitis, meningitis, encephalitis, and/or
        cerebritis