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Posoleucel for Nephropathy

Phase 2

Waitlist Available

Research Sponsored by AlloVir

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial will compare the effectiveness of Posoleucel to placebo in kidney transplant patients with high or low levels of BK virus.

Eligible Conditions

BK Virus Nephropathy
BK Virus Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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 of Treatment-Emergent Adverse Events [Safety and Tolerability]

Secondary outcome measures

Change in BK viremia, Posoleucel compared to placebo

Change in BK viremia, different dose regimens of Posoleucel compared to placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Posoleucel and PlaceboExperimental Treatment2 Interventions

Arm 2: Regimen B

Group II: PosoleucelExperimental Treatment1 Intervention

Arm 1: Regimen A

Group III: PlaceboPlacebo Group1 Intervention

Arm 3: Regimen A

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Posoleucel (formerly known as ALVR105) cells

2021

Completed Phase 2

~70

Placebo (visually identical to Posoleucel)

2021

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AlloVirLead Sponsor

11 Previous Clinical Trials

694 Total Patients Enrolled

Francesca Cardarelli, MDStudy DirectorAlloVir

Frequently Asked Questions

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

Is this study widely available in metropolitan areas?

"To limit travel as a barrier to participating, this trial is enrolling patients at 38 sites near them. A few of the locations include New york, Omaha and Cincinnati with 38 other enrolment centres."

Answered by AI

Are there still open slots in this trial for new participants?

"Unfortunately, this particular clinical trial is not presently looking for patients. Although, it is worth noting that there are 27 other similar studies that are enrolling candidates as we speak. This study was originally posted on March 22nd, 2021 and was last updated on May 10th, 2022."

Answered by AI

Are there any dangers associated with Posoleucel (formerly known as ALVR105; Viralym-M) cells for patients?

"Viralym-M (or Posoleucel), is a cells product in Phase 2 clinical trials. While there are indications of safety, more data regarding efficacy is needed before it can be given a higher rating."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Off-the-shelf Virus-specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-cell Transplantation

Tzannou, Ifigeneia, Anastasia Papadopoulou, Swati Naik, Kathryn Leung, Caridad A. Martinez, Carlos A. Ramos, George Carrum, et al.. 2017. “Off-the-shelf Virus-specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-cell Transplantation”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.73.0655.

clinicaltrials.govStudy

Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

2021. "Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04605484.