Magenau JM, Jaglowski SM, Uberti J, et al. A Phase 2 Trial of CD24Fc for Prevention of Graft-vs-Host Disease. Blood. 2023; (doi: 10.1182/blood.2023020250).
The results of a new study show that patients undergoing human leukocyte antigen-matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation (HSCT) with tacrolimus and methotrexate tolerated CD24Fc well, with high rates of severe acute graft-vs-host disease (GVHD)-free survival. The novel human CD24 fusion protein selectively targets and alleviates inflammation caused by damage-related molecular patterns underlying acute GVHD following myeloablative conditioning. The recommended dose was determined with a double-blind, placebo-controlled, dose-escalation phase, while an open-label expansion phase with matched controls assessed the safety and efficacy of CD24Fc in GHVD prevention. All patients received tacrolimus and methotrexate along with CD24Fc. Compared with single-dose regimens, a multidose regimen of CD24Fc resulted in sustained drug exposure and comparable safety outcomes. At day 180, grade 3-4 acute GVHD-free survival was 96.2% in the in the CD24Fc expansion group (CD24Fc multidose) and 73.6% in the matched controls. No participants in either group experienced dose-limiting toxicities.
Tags: AlloHCT, GVHD, Prevention, HSCT, cell therapy, graft-vs-host disease, graft-versus-host