1. Human Monoclonal Antibodies Neutralizing Cytomegalovirus (CMV) for Prophylaxis of CMV Disease: Report of a Phase I Trial in Bone Marrow Transplant Recipients
- Author
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Aulitzky, W. E., Schulz, T. F., Tilg, H., Niederwieser,, D., Larcher, K., Ostberg, L., Scriba, M., Martindale,, J., Stern, A. C., Grass, P., Mach, M., Dierich,, M. P., Huber, C., Aulitzky, W. E., Schulz, T. F., Tilg, H., Niederwieser,, D., Larcher, K., Ostberg, L., Scriba, M., Martindale,, J., Stern, A. C., Grass, P., Mach, M., Dierich,, M. P., and Huber, C.
- Abstract
The safety and pharmacokinetics of the two neutralizing human IgG1 monoclonal antibodies to cytomegalovirus (CMV) SDZ89-104 and 89-109 in bonemarrowtransplant (BM1)recipients was assessed in an open phase I trial. Thirteen patients, 8 seropositive and 5 seronegative for CMV, were treated with allogeneic or autologous bone marrow transplantation. SDZ 89-104 was given to 5 and SDZ 89-109 to 8 patients. Patients were divided into high-and low-dose groups. A fixed prestudy dose of 0.1 mg/kg was given 4 days before BMT. On days 3, 17, 31,45, 59, and 73, patients were treated with either 0.5 or 2 mg/kg of the respective antibody. Results indicate that doses of 2 mg/kg of SDZ 89-104 or SDZ 89-109 in alternating weeks can be safely administered to BMT patients. Serum trough levels measured by antiidiotype ELISA were ∼10 µg/ml after administration of 0.5 mg/kg and ∼50 µg/ml after treatment with 2 mg/kg of SDZ 89-104 or SDZ 89-109. High serum levels defined by antiidiotype ELISA techniques closely paralleled increased neutralizing activity. Serum half-lives calculatedfrom these data were ∼6 days
- Published
- 2017