Language
English
Publication Date
1-17-2023
Journal
Clinical Cancer Research
DOI
10.1158/1078-0432.CCR-22-2415
PMID
36628536
PMCID
PMC9843433
PubMedCentral® Posted Date
1-11-2023
PubMedCentral® Full Text Version
Post-print
Abstract
PURPOSE: Viral infections are a major cause of morbidity and mortality following allogeneic hematopoietic cell transplantation (allo-HCT). In the absence of safe and effective antiviral treatments, virus-specific T cells have emerged as a promising therapeutic option. Posoleucel is a multivirus-specific T-cell therapy for off-the-shelf use against six viral infections that commonly occur in allo-HCT recipients: adenovirus, BK virus (BKV), cytomegalovirus, Epstein-Barr virus, human herpes virus-6, and JC virus.
PATIENTS AND METHODS: We conducted an open-label, phase II trial to determine the feasibility and safety of posoleucel in allo-HCT recipients infected with one or more of these viruses. Infections were either unresponsive to or patients were unable to tolerate standard antiviral therapies. Fifty-eight adult and pediatric patients were enrolled and treated.
RESULTS: Posoleucel was well tolerated, with no cytokine release syndrome or other infusion-related toxicities; two patients (3.4%) developed Grade 2 and one patient (1.7%) Grade 3 GvHD during the trial. The overall response rate 6 weeks after the first posoleucel infusion was 95%, with a median plasma viral load reduction of 97%. Of the 12 patients who had two or more target viral infections identified at study entry, 10 (83%) had a clinical response for all evaluable viruses. Of the 23 patients treated for refractory BKV-associated hemorrhagic cystitis, 74% had resolution of symptoms and macroscopic hematuria by 6 weeks post-infusion.
CONCLUSIONS: In this open-label trial, treatment of refractory viral infections/disease in allo-HCT recipients with posoleucel was feasible, safe, and effective.
Keywords
Adult, Child, Humans, Antiviral Agents, Cell- and Tissue-Based Therapy, Epstein-Barr Virus Infections, Hematopoietic Stem Cell Transplantation, Herpesvirus 4, Human, Virus Diseases
Published Open-Access
yes
Recommended Citation
Pfeiffer, Thomas; Tzannou, Ifigeneia; Wu, Mengfen; et al., "Posoleucel, an Allogeneic, Off-the-Shelf Multivirus-Specific T-Cell Therapy, for the Treatment of Refractory Viral Infections in the Post-HCT Setting" (2023). Faculty and Staff Publications. 1561.
https://digitalcommons.library.tmc.edu/baylor_docs/1561