Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Adenovirus Infection
About this trial
This is an interventional treatment trial for Adenovirus Infection focused on measuring Allogeneic Hematopoietic Cell Transplant, Adenoviremia, Adenovirus, Stem Cell Transplant, Posoleucel, ALVR105, Bone Marrow Transplant
Eligibility Criteria
Inclusion Criteria:
- Male or female >1 year of age.
Has undergone allogeneic cell transplantation ≥21 days prior to randomization and demonstrated engraftment with an absolute neutrophil count >500/mm^3, AND has one of the following:
- AdV viremia DNA ≥10,000 copies/mL at screening, OR
Two consecutive and rising AdV viremia DNA results of ≥1,000 copies/mL at screening, AND
- has absolute lymphocyte count <180/mm3, OR
- has received T cell depletion.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and refrain from donating sperm or eggs for at least 90 days after treatment completion.
- Willing and able to provide signed informed consent.
- Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.
Exclusion Criteria:
- Grade >2 acute GVHD
- Ongoing therapy with high-dose systemic corticosteroids
- Grade 4 diarrhea
- Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
- Requirement for fraction of inspired oxygen >0.5 to maintain arterial oxygen saturation >90% (via pulse oximetry) or need for mechanical ventilation.
- Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other immunosuppressive T cell monoclonal antibodies within 28 days prior to randomization.
- Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to randomization.
- Use of vasopressors within 7 days prior to randomization.
- Use of any investigational antiviral agent, including brincidofovir, within 7 days prior to randomization.
- Lactating female unwilling to discontinue nursing prior to randomization.
- Severe allergy to any component of posoleucel or history of severe prior reactions to blood product transfusions.
- Positive for SARS-CoV-2 virus at screening.
Sites / Locations
- MD Anderson Cancer CenterRecruiting
- Phoenix Children's HospitalRecruiting
- City of HopeRecruiting
- University of California, Los Angeles (UCLA)Recruiting
- Lucile Packard Children's Hospital - Stanford UniversityRecruiting
- University of California, San Diego - Rady Children's HospitalRecruiting
- Children's Hospital Colorado - Center for Cancer and Blood DisordersRecruiting
- Children's National Medical CenterRecruiting
- University of Florida (UF) - GainesvilleRecruiting
- Ann and Robert H. Lurie Children's Hospital of ChicagoRecruiting
- Dana-Farber Cancer InstituteRecruiting
- University of MinnesotaRecruiting
- Washington University School of Medicine in St. LouisRecruiting
- Hackensack University Medical CenterRecruiting
- New York Presbyterian HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Duke University Medical CenterRecruiting
- Cleveland ClinicRecruiting
- University of OklahomaRecruiting
- University of Texas SouthwesternRecruiting
- Cook Children's Medical CenterRecruiting
- Intermountain HealthCare - Primary Children's HospitalRecruiting
- Seattle Children's HospitalRecruiting
- The Hospital for Sick Children (SickKids)Recruiting
- CHU Sainte-JustineRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- Fondazione IRCCS San Gerardo dei TintoriRecruiting
- A.O.R.N. Santobono-PausiliponRecruiting
- Azienda Ospedaliera di PadovaRecruiting
- Fondazione IRCCS Policlinico San MatteoRecruiting
- Ospedale Pediatrico Bambino GesùRecruiting
- Ospedale Regina MargheritaRecruiting
- Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo TrentoRecruiting
- Hospital Universitario Vall d'HebronRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
- Sahlgrenska University HospitalRecruiting
- Skane University Hospital LundRecruiting
- Karolinska University HospitalRecruiting
- Birmingham Children's HospitalRecruiting
- Bristol Royal Hospital for ChildrenRecruiting
- Royal Hospital for Children - GlasgowRecruiting
- University College London HospitalRecruiting
- St. Mary's Hospital, PaddingtonRecruiting
- Great Ormond Street Hospital for ChildrenRecruiting
- Royal Manchester Children's HospitalRecruiting
- Sheffield Children's NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Posoleucel + SoC
Placebo + SoC
Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria