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COMPLETEDPhase 2NCT04605484

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.

Lead sponsor: AlloVir•33 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

AlloVir

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 16, 2024Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment61

Start dateMar 2021

Last updatedMay 16, 2024

Condition

BK Virus Nephropathy BK Virus Infection

Locations shown

Keck Medical Center of USC

Los Angeles, California

Stanford University

Palo Alto, California

University of California Davis Medical Center

Sacramento, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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