Multicenter phase 2 trial of posoleucel for refractory viral infections in the post-HCT setting

Viral infections are a major cause of morbidity and mortality following allogeneic hematopoietic cell transplantation (alloHCT). Virus-specific T cells have emerged as a promising therapeutic option. Posoleucel is a T-cell therapy for off-the-shelf use against six viral infections that commonly occur in alloHCT recipients: adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpes virus-6, and JC virus. A multicenter phase 2 trial evaluated posoleucel in alloHCT recipients infected with one or more of these viruses, either unresponsive or unable to tolerate standard antiviral therapies. Posoleucel was well tolerated. The overall response rate 6 weeks after the first posoleucel infusion was 95%, with a median plasma viral load reduction of 97%. Of the patients treated for refractory BKV-associated hemorrhagic cystitis, 74% had resolution of symptoms and macroscopic hematuria by 6 weeks post-infusion. The authors conclude that treatment of refractory viral infections in alloHCT recipients with posoleucel was feasible, safe, and effective.