Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
NCT ID: NCT04933968
Last Updated: 2024-06-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
17 participants
INTERVENTIONAL
2022-03-21
2024-01-31
Brief Summary
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Detailed Description
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This trial will consist of two parts: Part A is Dose Escalation and Part B is Cohort Expansion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo, visually identical to ALVR106
Placebo
Infusion, visually identical to ALVR106
ALVR106
ALVR106, visually identical to placebo
ALVR106
Infusion, visually identical to placebo
Interventions
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ALVR106
Infusion, visually identical to placebo
Placebo
Infusion, visually identical to ALVR106
Eligibility Criteria
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Inclusion Criteria
* Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
* Diagnosis of Upper or mild Lower Respiratory Tract Infection
Exclusion Criteria
* Infection by novel coronavirus disease 2019 (COVID-19)
* For HCT patients, evidence of Grade \>2 GVHD; and for SOT patients, any history or evidence of GVHD
17 Years
75 Years
ALL
No
Sponsors
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AlloVir
INDUSTRY
Responsible Party
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Locations
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Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States
City of Hope
Duarte, California, United States
University of Florida - Division of Hematology & Oncology
Gainesville, Florida, United States
University of Miami - Sylvester Cancer Center
Miami, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Cancer Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
MD Anderson
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
Papayanni PG, Koukoulias K, Kuvalekar M, Watanabe A, Velazquez Y, Ramos CA, Leen AM, Vasileiou S. T cell immune profiling of respiratory syncytial virus for the development of a targeted immunotherapy. Br J Haematol. 2023 Aug;202(4):874-878. doi: 10.1111/bjh.18933. Epub 2023 Jun 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P-106-001
Identifier Type: -
Identifier Source: org_study_id
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