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

Phase 2

Completed

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

• Registration Number: NCT04605484
• Lead Sponsor: AlloVir

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-28
• Study Start: 2021-03-22
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Status Verified: 2024-04
• Results First Submitted: 2024-04-23
• Results First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Results First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (visually identical to Posoleucel)	Arm 3: Regimen A
Posoleucel	Posoleucel (formerly known as ALVR105) cells	Arm 1: Regimen A
Posoleucel and Placebo	Placebo (visually identical to Posoleucel)	Arm 2: Regimen B
Posoleucel and Placebo	Posoleucel (formerly known as ALVR105) cells	Arm 2: Regimen B

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in BK Viral Load	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.

Trial Locations

Locations (33)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Northwestern University Transplant Center; 🇺🇸 Chicago, Illinois, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

John Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Harvard Medical School - Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Erie County Medical Center; 🇺🇸 Buffalo, New York, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Weil Medical College - NY Presbyterian Hospital; 🇺🇸 New York, New York, United States

University of Cincinnati Hospital; 🇺🇸 Cincinnati, Ohio, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

UPMC Pinnacle-Harrisburg Hospital; 🇺🇸 Harrisburg, Pennsylvania, United States

UPMC Montefiore Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Inova Fairfax Medical Center; 🇺🇸 Falls Church, Virginia, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States