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

NCT04605484 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: P-105-201
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 33

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.

Conditions

BK Virus Nephropathy; BK Virus Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

  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.

  Day 1 to Week 24

Secondary Outcomes (1)

• Change From Baseline in BK Viral Load

  Baseline and Week 24

Study Arms (3)

Posoleucel

EXPERIMENTAL

Arm 1: Regimen A

Biological: Posoleucel (formerly known as ALVR105) cells

Posoleucel and Placebo

EXPERIMENTAL

Arm 2: Regimen B

Biological: Posoleucel (formerly known as ALVR105) cells; Biological: Placebo (visually identical to Posoleucel)

Placebo

PLACEBO COMPARATOR

Arm 3: Regimen A

Biological: Placebo (visually identical to Posoleucel)

Interventions

Posoleucel (formerly known as ALVR105) cells BIOLOGICAL

Infusion

Posoleucel; Posoleucel and Placebo

Placebo (visually identical to Posoleucel) BIOLOGICAL

Infusion

Placebo; Posoleucel and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AlloVir: lead

Study Sites (33)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Stanford University

Palo Alto, California, 94306, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northwestern University Transplant Center

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

John Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Harvard Medical School - Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Weil Medical College - NY Presbyterian Hospital

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University of Cincinnati Hospital

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

UPMC Pinnacle-Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center

Dallas, Texas, 75204, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Medical Center

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (4)

• Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.

  PMID: 28783452 BACKGROUND

• Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.

  PMID: 38470444 BACKGROUND

• Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

  PMID: 39382091 DERIVED

• Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.

  PMID: 38597860 DERIVED

MeSH Terms

Interventions

Cell Count

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Physiological Phenomena

Results Point of Contact

• Title: Richard Riese
• Organization: AlloVir, Inc.

rriese@allovir.com

617-433-2605

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: March 22, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)