Clinical Trials Directory

Trials / Completed

CompletedNCT04693637

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
26 (actual)
Sponsor
AlloVir · Industry
Sex
All
Age
1 Year
Healthy volunteers
Not accepted

Summary

This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

Detailed description

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT. There are 2 parts to the study, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPosoleucel (ALVR105)Administered as 2-4 milliliter infusion

Timeline

Start date
2021-01-15
Primary completion
2023-01-19
Completion
2023-01-19
First posted
2021-01-05
Last updated
2024-05-09
Results posted
2024-05-07

Locations

16 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04693637. Inclusion in this directory is not an endorsement.