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

NCT05305040 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2024-05-16

Study results available
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Summary

This is a Phase 3 study to evaluate posoleucel (ALVR105, 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.

Conditions

  • Adenovirus Infection
  • BK Virus Infection
  • Cytomegalovirus Infections
  • Epstein-Barr Virus Infections
  • Human Herpes Virus-6 Infection
  • JC Virus Infection

Interventions

BIOLOGICAL

Posoleucel (ALVR105)

Administered as 2-4 milliliter infusion, visually identical to placebo

BIOLOGICAL

Placebo

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Sponsors & Collaborators

  • AlloVir

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2024-01-30
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Italy
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305040 on ClinicalTrials.gov