Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Reason given: Study discontinued as DSMB determined it was futile. No safety concerns were noted.
Key facts
- Where
- Atlanta, Aurora, Baltimore, Birmingham, Boston, Buffalo, Charlotte, Charlottesville, Columbus, Dallas, Duarte, Gainesville, Hackensack, Indianapolis, Kansas City, Los Angeles, Maywood, Milwaukee, Minneapolis, New Haven, New York, Palo Alto, Philadelphia, Portland, Richmond, Salt Lake City, San Francisco, Scottsdale, Seattle, St Louis, Stony Brook, Tampa, and Washington D.C., United StatesSee the 35 sites
- Phase
- Phase 2/3
Where in United States
- Northside HospitalAtlanta, United StatesNo longer taking part
- University of Colorado HospitalAurora, United StatesNo longer taking part
- University of MarylandBaltimore, United StatesNo longer taking part
- University of Alabama at Birmingham, Children's of AlabamaBirmingham, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- Roswell Park Cancer InstituteBuffalo, United StatesNo longer taking part
- Carolinas Medical Center/LevineCharlotte, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- Nationwide Children's HospitalColumbus, United StatesNo longer taking part
- Children's Medical Center DallasDallas, United StatesNo longer taking part
- City of HopeDuarte, United StatesNo longer taking part
- University of Florida (UF) - GainesvilleGainesville, United StatesNo longer taking part
- Hackensack University Medical CenterHackensack, United StatesNo longer taking part
- Indiana University Hospital Simon Comprehensive Cancer CenterIndianapolis, United StatesNo longer taking part
- Children's Mercy HospitalKansas City, United StatesNo longer taking part
- University of Kansas HospitalKansas City, United StatesNo longer taking part
- University of California Los Angeles (UCLA).Los Angeles, United StatesNo longer taking part
- Loyola University Medical CenterMaywood, United StatesNo longer taking part
- Froedtert Hospital and the Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesNo longer taking part
- Yale University School of Medicine - Yale Cancer CenterNew Haven, United StatesNo longer taking part
- Columbia UniversityNew York, United StatesNo longer taking part
- Weill Cornell Medical CollegeNew York, United StatesNo longer taking part
- Stanford UniversityPalo Alto, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Oregon Health Science UniversityPortland, United StatesNo longer taking part
- Virginia Commonwealth UniversityRichmond, United StatesNo longer taking part
- University of Utah/Primary Childrens HospitalSalt Lake City, United StatesNo longer taking part
- University of California San Francisco-Benioff Children's HospitalSan Francisco, United StatesNo longer taking part
- Honor Health Research InstituteScottsdale, United StatesNo longer taking part
- Fred Hutchinson Cancer Research CenterSeattle, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Stony Brook University Hospital Cancer CenterStony Brook, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
- Childrens National Health SystemWashington D.C., United StatesNo longer taking part
Trial details
- Who runs it
- AlloVir
- Trial code
- NCT05305040
- Record updated
- 16 May 2024
- Original description
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.Read full original descriptionShow less
Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Inclusion: Any age at the day of screening visit; No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV; Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing; 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; Matched or Mismatched unrelated donor; Use of umbilical cord blood as stem cell source; Ex vivo graft manipulation resulting in T cell depletion; Received anti-thymocyte globulin or alemtuzumab (Campath-1H).
Exclusion: History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization; Known history or current (suspected) diagnosis of Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies; Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >1.0 mg/kg/day) within 24 hours prior to dosing; Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections; Relapse of primary malignancy other than minimal residual disease; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Evidence of active Grade >2 acute GVHD.