Anil Chandraker, Anil Regmi, Reginald Gohh, Akhil Sharma, E Steve Woodle, Mohammed J Ansari, Vinay Nair, Ling-Xin Chen, Tarek Alhamad, Silas Norman, Diane Cibrik, Manpreet Singh, Arnold Alper, Divya Jain, Ziad Zaky, Stuart Knechtle, Asif Sharfuddin, Gaurav Gupta, Bonnie E Lonze, Jo-Anne H Young, Deborah Adey, Arman Faravardeh, Darshana M Dadhania, Ana P Rossi, Diana Florescu, Francesca Cardarelli, Julie Ma, Sarah Gilmore, Spyridoula Vasileiou, Peter Jindra, David Wojciechowski
BACKGROUND: Kidney transplant recipients with BK virus infection are at risk of developing BK virus-associated nephropathy, allograft rejection, and subsequent graft loss. There are no approved treatments for BK virus infection. Posoleucel is an off-the-shelf, allogeneic, multivirus-specific T cell investigational therapy targeting BK virus, as well as five other opportunistic viruses: adenovirus, cytomegalovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. METHODS: In this phase 2, double-blind study, kidney transplant recipients with BK viremia were randomized 1:1:1 to receive posoleucel weekly for 3 weeks then every 14 days (bi-weekly dosing) or every 28 days (monthly dosing), or placebo for 12 weeks...
March 12, 2024: Journal of the American Society of Nephrology: JASN