Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
BK Virus Infection, Hemorrhagic Cystitis
About this trial
This is an interventional treatment trial for BK Virus Infection focused on measuring Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel
Eligibility Criteria
Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate in the study:
- Male or female ≥1 year of age.
- Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
- Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
Diagnosed with HC based on the following criteria (all 3 criteria must be met):
- Clinical signs and/or symptoms of cystitis.
- Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
- Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
- At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.
Key Exclusion Criteria
Participants who meet any of the following criteria will be excluded from participation in the study:
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
- Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
- Evidence of active Grade >2 acute graft versus host disease (GVHD).
- Uncontrolled or progressive bacterial or fungal infections.
- Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
- Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
- Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
- Pregnant or lactating or planning to become pregnant.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- City of Hope National Medical CenterRecruiting
- Children's Hospital of Los AngelesRecruiting
- Yale University School of Medicine - Yale Cancer CenterRecruiting
- Children's National Medical CenterRecruiting
- University of MiamiRecruiting
- MoffittRecruiting
- Northside HospitalRecruiting
- Northwestern Memorial HospitalRecruiting
- University of Kansas Cancer CenterRecruiting
- Johns Hopkins MedicineRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Massachusetts General HospitalRecruiting
- University of MinnesotaRecruiting
- Children's Mercy Hospital - Kansas CityRecruiting
- University of Nebraska Medical CenterRecruiting
- Hackensack University Medical CenterRecruiting
- Roswell Park Comprehensive Cancer CenterRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- Ohio State University Medical Center (OSUMC)Recruiting
- Oregon Health & Science UniversityRecruiting
- Children's Hospital of Philadelphia (CHOP)Recruiting
- The University of Texas Southwestern Medical CenterRecruiting
- Virginia Commonwealth UniversityRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- Froedtert Hospital and the Medical College of WisconsinRecruiting
- CHU de Lille - Hopital Claude HuriezRecruiting
- CHU de Nantes - Hôtel-DieuRecruiting
- AP-HP Hopital Saint-LouisRecruiting
- HCL Centre Hospitalier Lyon SudRecruiting
- IUCT-OncopoleRecruiting
- Azienda Ospedaliero-Universitaria CareggiRecruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- Ospedale Pediatrico Bambino GesùRecruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRecruiting
- Istituto Clinico HumanitasRecruiting
- Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo TrentoRecruiting
- Chonnam National University Hwasun HospitalRecruiting
- Asan Medical CenterRecruiting
- Pusan National University HospitalRecruiting
- Samsung Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Seoul St. Mary's Hospital, The Catholic University of KoreaRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Hospital Clinic BarcelonaRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Regional Universitario de MalagaRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
- Karolinska University HospitalRecruiting
- University Hospitals Bristol NHS Foundation TrustRecruiting
- Queen Elizabeth University Hospital - GlasgowRecruiting
- Great Ormond Street Hospital for ChildrenRecruiting
- Hammersmith HospitalRecruiting
- The Royal Marsden NHS Foundation TrustRecruiting
- University College London HospitalRecruiting
- Nottingham University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo