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

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: BK Virus Infection; BK Virus Nephropathy
• Intervention / Treatment: Biological: Posoleucel (formerly known as ALVR105) cells; Biological: Placebo (visually identical to Posoleucel)

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 16 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. (If a matching Posoleucel line is not available, the following patient data will be collected:

demographic data and human leukocyte antigen [HLA] type.)

• 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.

• A female patient is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:

  • She is a woman of non-childbearing potential (WONCBP) as defined in the protocol
  • She is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method as described in the protocol during the study treatment period and for at least 90 days after the last dose of study treatment. The Investigator should evaluate the potential for contraceptive method failure.

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

How is the study designed?

Design Details

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

Number of Arms

3

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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Patients will be monitored for adverse events following each infusion and during the dosing period.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BK viremia, Posoleucel compared to placebo	Change in BK viral load in patients receiving Posoleucel compared to patients receiving placebo, based on mean +/- standard deviation of BK viral load as determined by the BK viral load assay performed at the central laboratory.	24 weeks
Change in BK viremia, different dose regimens of Posoleucel compared to placebo	Difference in mean BK viral load +/- standard deviation in Arm 1 versus placebo Arm 3, as compared to the difference in mean BK viral load in Arm 2 versus placebo Arm 3, -all as determined by the BK viral load assay performed at the central laboratory.	24 weeks

Collaborators and Investigators

• Sponsor: AlloVir
• Investigators: Study Director: Francesca Cardarelli, MD, AlloVir

Publications and helpful links

General Publications

• Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. 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. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.

Study record dates

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): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Viremia
• 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