NCT05179057

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

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: AlloVir · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed description

During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.

Conditions

• Adenovirus Infection

Interventions

Type	Name	Description
DRUG	Posoleucel	Administered as 2-4 milliliter infusion, visually identical to placebo
DRUG	Placebo	Administered as 2-4 milliliter infusion, visually identical to Posoleucel

Timeline

• Start date: 2022-04-26
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2022-01-05
• Last updated: 2024-05-08
• Results posted: 2024-05-08

Locations

47 sites across 6 countries: United States, Canada, Italy, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study