Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

Phase 3 Terminated 57 enrolled AlloVir

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

Timeline

Start: 2022-04-26
Primary completion: 2024-01-31
Completion: 2024-01-31

Outcome

Missed primary endpoint

Stopped: “Study discontinued as DSMB determined it was futile. No safety concerns were noted.”

registry analysis (superiority test); Posoleucel, Then Placebo vs Placebo, Then Posoleucel; Odds Ratio (OR) 0.98 (95% CI 0.26 to 3.69) NCT05179057 ↗

Publications

Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Posoleucel	Cell therapy	—	—