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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
Not Recruiting
Trial ID: NCT05179057
Purpose
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
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
* Undergone allogeneic cell transplantation ≥21 days prior to dosing
* Meet one of the below criteria:
1. AdV viremia DNA ≥10,000 copies/mL, OR
2. AdV viremia DNA results of ≥1,000 copies/mL, AND
1. has absolute lymphocyte count \<180/mm3, OR
2. has received T cell depletion OR
3. had a cord blood transplant.
Exclusion Criteria:
* Grade 3 or higher 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.
Intervention(s):
drug: Posoleucel
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maninder Singh
msclinic@stanford.edu