Creating the World’s First Off-the-Shelf Viral-Specific Cytomegalovirus T-Lymphocyte Bank
Mitchell Cairo, M.D., Receives $3.5 Million U.S. Army Grant to Develop a Bank of Cryopreserved Viral-Specific Immune Cells to Treat Newborns with Congenital CMV Infection
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Mitchell Cairo, M.D., professor of pediatrics, medicine, cell and molecular physiology, and pathology, microbiology, and immunology at New York Medical College, has been awarded a $3.5 million, four-year grant from the U.S. Army to advance a novel treatment for congenital cytomegalovirus (cCMV) infection in neonates. The grant will support the development of the world’s first “off-the-shelf” bank of cryopreserved CMV-specific cytotoxic T cells (CTLs) from universal donors, potentially making this promising cellular therapy available to neonates at hospitals across the United States.
“Neonates born with moderate to severe cCMV have a dismal outcome, with 40 to 60 percent developing deafness and severe neurodevelopmental disabilities,” says Dr. Cairo. “Current treatment only includes antibiotic therapy, which both fails to eradicate the CMV infection and results in bone marrow suppression.”
Dr. Cairo is currently the principal investigator for a national clinical trial comparing the safety and, more importantly, effectiveness of maternal donor-derived CMV-specific memory CTLs in neonates with moderate to severe infection.
“While the preliminary results have been outstanding, this approach is limited to only institutions with the capability of manufacturing clinical-grade CMV CTLs and the availability of a maternal donor,” says Dr. Cairo. “Unfortunately, only about a dozen academic hospital centers have the capability and experience to manufacture these maternal donor-derived CMV CTLs.”
The new grant will address these limitations by funding the development of an “off-the-shelf” allogeneic donor bank of cryopreserved CMV CTLs, manufactured according to strict federal guidelines to meet good manufacturing practice standards. The bank will contain CMV-CTLs representing 50 different Human Leukocyte Antigen subtypes, allowing clinicians to potentially identify a suitable cell product without requiring a new maternal donation and manufacturing process for each patient.
“This bank will further and extend the treatment of neonates with moderate to severe congenital CMV infection to be potentially treated anywhere in the United States by the availability of shipping ‘off-the-shelf’ CMV CTLs directly to neonatal units across the country in a future clinical trial,” says Dr. Cairo.
