The Annual Report for the IND covering a University of Wisconsin (UW) clinical trial evaluating the safety of donor Viral-Specific T cells against CMV (cytomegalovirus) infection was submitted to the FDA CBER this week.
This Phase I clinical trial (NCT03950414) is open to accrual of adult solid organ transplant recipients with CMV infection that is refractory to standard anti-viral therapy.
In the UW Program for Advanced Cell Therapy Cell Manufacturing facility, a state-of-the-art Good Manufacturing Practices (GMP) laboratory, haploidentical donor white blood cells that specifically target CMV infected cells are isolated. These CMV-specific immune cells are administered to the solid organ transplant recipient with the goal of restoring the recipient’s immunity against CMV.
For information regarding participation in the clinical trial, contact Christopher Roginski (608-263-4505) firstname.lastname@example.org.