Summary

Eligibility
for people ages 1 year and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

Official Title

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

Details

During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.

Keywords

Adenovirus Infection Allogeneic Hematopoietic Cell Transplant Adenoviremia Adenovirus Stem cell transplant Posoleucel ALVR105 Infections Communicable Diseases Adenoviridae Infections

Eligibility

You can join if…

Open to people ages 1 year and up

  • 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/mm3, 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, San Diego - Rady Children's Hospital accepting new patients
    San Diego California 92123 United States
  • Children's Hospital Colorado - Center for Cancer and Blood Disorders accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AlloVir
ID
NCT05179057
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated