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

Completed · Phase 2 · Has a placebo group

Conditions studied: BK Virus Nephropathy, BK Virus Infection

In brief

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.

Key facts

Study ID

NCT04605484

Run by

AlloVir

People needed

61

Starts

2021-03-22

Expected to finish

2022-10-20

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• University of Maryland Medical Center — Baltimore, Maryland, 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
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Erie County Medical Center — Buffalo, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Weil Medical College - NY Presbyterian Hospital — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Cincinnati Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• UPMC Pinnacle-Harrisburg Hospital — Harrisburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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