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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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Male or female 1 year of age or older
- Undergone allogeneic cell transplantation ≥21 days prior to dosing
- Meet one of the below criteria:
- AdV viremia DNA ≥10,000 copies/mL, OR
- AdV viremia DNA results of ≥1,000 copies/mL, AND
- has absolute lymphocyte count <180/mm3, OR
- has received T cell depletion OR
- had a cord blood transplant.
Exclusion Criteria:
- Grade >2 acute GVHD
- Ongoing therapy with high-dose systemic corticosteroids
- Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
- Pregnant or lactating female unwilling to discontinue nursing prior to randomization
- History of severe prior reactions to blood product transfusions. NOTE: Other protocol-defined inclusion/exclusion criterion may apply.
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Study Stats
Protocol No.
22-001060
Category
Immune System/Transplant Related Disorders
Pediatric and Prenatal Disorders
Principal Investigator
Satiro Nakamura De Oliveira
Contact
Location
- UCLA Westwood