Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Trial ID or NCT#
NCT05179057
Status
RECRUITING
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
Eligibility Criteria
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Orly R. Klein, MD
Contact us to find out if this trial is right for you.
Contact
Maninder Singh
msclinic@stanford.edu
View on ClinicalTrials.gov
