Open Actively Recruiting

Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
1 Year
Maximum Age
N/A

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.

Join this Trial

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Study Stats
Protocol No.
22-001060
Category
Pediatrics
Principal Investigator
Satiro Nakamura De Oliveira
Contact
Andres Vargas Gonzalez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05179057
For detailed technical eligibility, visit ClinicalTrials.gov.