Trial Information

Protocol For The Emergency Use Of Adoptive Immunotherapy With CMV-Specific T Cells Following HLA-Matched Unrelated Donor Bone Marrow Transplant Of An Infant With ADA-SCIDs And Pre Transplant CMV Infection

OBJECTIVES:

- To determine if adoptive immunotherapy with donor-derived CD4+ and CD8+ CMV- specific
cytotoxic lymphocyte cell lines can augment T-cell immunity and treat CMV infection
post transplant in a patient with severe combined immunodeficiency syndrome.

OUTLINE: The patient will undergo HLA-matched unrelated donor bone marrow transplantation
from a CMV-seropositive donor after undergoing conditioning with 200cGy total-body
irradiation per protocol FHCRC Protocol 1227.

CD8-positive and CD4-positive CMV-specific T cells are collected from the donor and used to
generate T-cell lines.

If the patient has progressive or persistent CMV infection, then she will receive donor T
cells IV over 30 minutes. Infusions may be repeated after at least 14 days if the previous
infusion was well tolerated and if the CMV infection is persistent or increasing.

The patient undergoes blood sample collection at baseline and 7 days after T-cell infusion
to assess CMV-specific T-cell response.