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

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Key information

Conditions

BK Virus Nephropathy BK Virus Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Keck Medical Center of USC, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posoleucel (formerly known as ALVR105) cells

Biological

Infusion

Placebo (visually identical to Posoleucel)

Biological

Infusion

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

AlloVir

Industry

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 28, 2020
Registry last updated: May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed