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

April 23, 2024 updated by: AlloVir

Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Dosing Interval, 2-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred Posoleuccel (ALVR105) Multivirus-specific T Cells in Kidney Transplant Recipients With Either High or Low Levels of BK Viremia

The purpose of this study is to compare Posoleucel (formerly known as ALVR105; Viralym-M) to placebo in kidney transplant recipients who have high or low levels of BK virus in their blood.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck Medical Center of USC
      • Palo Alto, California, United States, 94306
        • Stanford University
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Transplant Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Harvard Medical School - Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10021
        • Weil Medical College - NY Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • UPMC Pinnacle-Harrisburg Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Montefiore Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75204
        • Baylor University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Center
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment
  • At least 1 identified, suitably matched Posoleucel (ALVR105) cell line for infusion is available.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • Undergone allogeneic hematopoietic cell transplantation
  • Evidence or history of graft versus host disease (GVHD) or cytokine release syndrome (CRS).
  • Uncontrolled or progressive bacterial or fungal infections
  • Known or presumed pneumonia
  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
  • Pregnant or lactating or planning to become pregnant.
  • Weight <40 kg.
  • Patients who received, or planned to receive abatacept or belatacept, within 3 months of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Posoleucel
Arm 1: Regimen A
Biological: Posoleucel (formerly known as ALVR105) cells
Infusion
Experimental: Posoleucel and Placebo
Arm 2: Regimen B
Biological: Posoleucel (formerly known as ALVR105) cells
Infusion
Biological: Placebo (visually identical to Posoleucel)
Infusion
Placebo Comparator: Placebo
Arm 3: Regimen A
Biological: Placebo (visually identical to Posoleucel)
Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time Frame: Day 1 to Week 24

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study.

Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.
Day 1 to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in BK Viral Load
Time Frame: Baseline and Week 24
BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlloVir

Investigators

  • Study Director: Francesca Cardarelli, MD, AlloVir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-105-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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