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Virus Therapy

Posoleucel for Adenovirus Infections

Phase 3

Waitlist Available

Research Sponsored by AlloVir

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergone allogeneic cell transplantation ≥21 days prior to dosing

has received T cell depletion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 34 weeks

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of Posoleucel for treating adenovirus infection in children and adults receiving a stem cell transplant from a donor.

Who is the study for?

This trial is for pediatric and adult patients who've had a cell transplant at least 21 days ago and are now facing adenovirus infections. They must have significant levels of the virus in their blood, possibly with low lymphocyte counts or after receiving T cell depletion therapy. It's not open to those on high-dose steroids, women who are pregnant/nursing unless they stop, or anyone with uncontrolled infections besides adenovirus.Check my eligibility

What is being tested?

The study is testing Posoleucel against a placebo in participants who have received standard care post-cell transplantation. The goal is to see if Posoleucel can safely and effectively treat adenovirus infections that occur after this type of transplant.See study design

What are the potential side effects?

While specific side effects for Posoleucel aren't listed here, similar treatments may cause immune reactions, infusion-related discomforts, fatigue, allergic responses or worsen existing infections. Each participant might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have received a type of cell transplantation called allogeneic transplantation at least 21 days before starting the study.

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You have undergone a cord blood transplant in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of treatment-emergent adverse events (TEAEs)

Proportion of participants with undetectable adenovirus infection

Secondary outcome measures

Incidence of AdV disease recurrence

Mean area under the curve (AUC) AdV viral load

Overall disease progression or non-relapse mortality

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Posoleucel + SoCExperimental Treatment1 Intervention

Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria

Group II: Placebo + SoCPlacebo Group1 Intervention

Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AlloVirLead Sponsor

11 Previous Clinical Trials

704 Total Patients Enrolled

3 Trials studying Adenovirus Infections

413 Patients Enrolled for Adenovirus Infections

Media Library

Posoleucel (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05179057 — Phase 3

Adenovirus Infections Research Study Groups: Placebo + SoC, Posoleucel + SoC

Adenovirus Infections Clinical Trial 2023: Posoleucel Highlights & Side Effects. Trial Name: NCT05179057 — Phase 3

Posoleucel (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05179057 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are the different sites where this trial is taking place?

"Children's Hospital Colorado - Center for Cancer and Blood Disorders in Aurora, Colorado, Children's National Medical Center in Washington, District of Columbia, University of California, San Diego - Rady Children's Hospital in San Diego, California are a few of the 8 other locations running this trial."

Answered by AI

Has Posoleucel completed the necessary steps for FDA approval?

"There is some data supporting efficacy and multiple rounds of data supporting safety for Posoleucel, so it received a score of 3."

Answered by AI

Is this research looking for new participants?

"That is affirmative, the online clinicaltrials.gov database has this trial listed as currently seeking participants. The first posting was on May 11th, 2022 with the most recent update being on August 2nd of the same year. They are looking for a total of 80 individuals at 8 different locations."

Answered by AI

How many people are signing up to participate in this research?

"In order for this study to move forward, 80 patients that fit the pre-determined criteria must enroll. Those who qualify and are interested can participate in the trial at Children's Hospital Colorado - Center for Cancer and Blood Disorders in Aurora, Colorado or Children's National Medical Center in Washington, District of Columbia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05179057.