Loading clinical trials...

COMPLETEDPHASE2

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

NCT04605484•AlloVir

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
•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

Locations (33)

Keck Medical Center of USC

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

Piedmont Hospital

Atlanta, Georgia, United States

Northwestern University Transplant Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Hospital

Indianapolis, Indiana, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Key Dates

Start Date

March 22, 2021

Primary Completion Date

October 20, 2022

Completion Date

October 20, 2022

Last Updated

May 16, 2024

Enrollment

ACTUAL participants

Conditions

BK Virus NephropathyBK Virus Infection

Interventions

Posoleucel (formerly known as ALVR105) cells

BIOLOGICAL

Placebo (visually identical to Posoleucel)

BIOLOGICAL

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient

NCT04542733

Kidney Transplant InfectionBK Virus Infection

View study

RECRUITINGPHASE1

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

NCT06926894

Epstein-Barr VirusCytomegalovirus Infections+3 more

View study

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: March 29, 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia.

Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant