Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia
NCT ID: NCT04605484
Last Updated: 2024-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2021-03-22
2022-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Posoleucel
Arm 1: Regimen A
Posoleucel (formerly known as ALVR105) cells
Infusion
Posoleucel and Placebo
Arm 2: Regimen B
Posoleucel (formerly known as ALVR105) cells
Infusion
Placebo (visually identical to Posoleucel)
Infusion
Placebo
Arm 3: Regimen A
Placebo (visually identical to Posoleucel)
Infusion
Interventions
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Posoleucel (formerly known as ALVR105) cells
Infusion
Placebo (visually identical to Posoleucel)
Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AlloVir
INDUSTRY
Responsible Party
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Locations
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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
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Medical Center
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P-105-201
Identifier Type: -
Identifier Source: org_study_id
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