Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
NCT ID: NCT04693637
Last Updated: 2024-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
26 participants
INTERVENTIONAL
2021-01-15
2023-01-19
Brief Summary
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Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
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Detailed Description
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There are 2 parts to the study, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion
Interventions
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Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion
Eligibility Criteria
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Inclusion Criteria
* Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening
* Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
* Meet one or more of the following criteria at the time of randomization:
* Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
* Haploidentical donor
* Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR
* Use of umbilical cord blood as stem cell source
* Ex vivo graft manipulation resulting in T cell depletion
* Lymphocyte Count \<180/mm3 and/or cluster of differentiation 4 (CD4) Count \<50/mm3
Exclusion Criteria
* Evidence of active Grade \>2 acute GVHD
* Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
* Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 mg/kg/day) within 24 hours prior to dosing
* Relapse of primary malignancy other than minimal residual disease
1 Year
ALL
No
Sponsors
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AlloVir
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Childrens National Medical Center
Northwest Rectangle, District of Columbia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Kansas Hospital
Westwood, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Stony Brook University Hospital Cancer Center
Stony Brook, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Medical Center Dallas
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.
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.
Dadwal SS, Bansal R, Schuster MW, Yared JA, Myers GD, Matzko M, Adnan S, McNeel D, Ma J, Gilmore SA, Vasileiou S, Leen AM, Hill JA, Young JH. Final outcomes from a phase 2 trial of posoleucel in allogeneic hematopoietic cell transplant recipients. Blood Adv. 2024 Sep 10;8(17):4740-4750. doi: 10.1182/bloodadvances.2023011562.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P-105-202 Phase 2
Identifier Type: -
Identifier Source: org_study_id
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