search
Back to results

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

Primary Purpose

BK Virus Nephropathy, BK Virus Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Posoleucel (formerly known as ALVR105) cells
Placebo (visually identical to Posoleucel)
Sponsored by
AlloVir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BK Virus Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck Medical Center of USC
  • Stanford University
  • University of California Davis Medical Center
  • University of California, San Francisco Medical Center
  • Piedmont Hospital
  • Northwestern University Transplant Center
  • Loyola University Medical Center
  • Indiana University Hospital
  • University of Kansas Hospital
  • Tulane University School of Medicine
  • University of Maryland Medical Center
  • John Hopkins Hospital
  • Harvard Medical School - Brigham & Women's Hospital
  • University of Michigan Medical Center
  • University of Minnesota
  • Washington University School of Medicine
  • University of Nebraska Medical Center
  • Erie County Medical Center
  • North Shore University Hospital
  • NYU Langone Medical Center
  • Weil Medical College - NY Presbyterian Hospital
  • Duke University
  • University of Cincinnati Hospital
  • Cleveland Clinic Foundation
  • UPMC Pinnacle-Harrisburg Hospital
  • UPMC Montefiore Hospital
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Baylor University Medical Center
  • UT Southwestern Medical Center
  • University of Virginia
  • Inova Fairfax Medical Center
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Posoleucel

Posoleucel and Placebo

Placebo

Arm Description

Arm 1: Regimen A

Arm 2: Regimen B

Arm 3: Regimen A

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 15, 2020
Last Updated
July 9, 2023
Sponsor
AlloVir
search

1. Study Identification

Unique Protocol Identification Number
NCT04605484
Brief Title
Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlloVir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Virus Nephropathy, BK Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posoleucel
Arm Type
Experimental
Arm Description
Arm 1: Regimen A
Arm Title
Posoleucel and Placebo
Arm Type
Experimental
Arm Description
Arm 2: Regimen B
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm 3: Regimen A
Intervention Type
Biological
Intervention Name(s)
Posoleucel (formerly known as ALVR105) cells
Intervention Description
Infusion
Intervention Type
Biological
Intervention Name(s)
Placebo (visually identical to Posoleucel)
Intervention Description
Infusion
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Patients will be monitored for adverse events following each infusion and during the dosing period.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in BK viremia, Posoleucel compared to placebo
Description
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.
Time Frame
24 weeks
Title
Change in BK viremia, different dose regimens of Posoleucel compared to placebo
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Cardarelli, MD
Organizational Affiliation
AlloVir
Official's Role
Study Director
Facility Information:
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern University Transplant Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Harvard Medical School - Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weil Medical College - NY Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
University of Cincinnati Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
UPMC Pinnacle-Harrisburg Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
UPMC Montefiore Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Medical Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28783452
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs