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
To compare the percent of participants who have clearance of AdV viremia at Day 29 in participants receiving posoleucel and SoC to that in participants receiving placebo and SoC.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of posoleucel (ALVR105) as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC. Approximately 80 participants at approximately 40 clinical sites in the US and Europe will be enrolled into the study and randomized 1:1 to receive posoleucel or placebo. Randomization will be stratified by level of viremia and age.
MoreChild to Adult
Patients greater than 1 year of age post allogeneic HCT with AdV viremia.
1. Male or female >1 year of age. 2. Has undergone allogeneic (including umbilical cord) cell transplantation greater than or equal to 21 days prior to randomization and has demonstrated engraftment with an absolute neutrophil count >500/mm3, AND has one of the following: a. AdV viremia DNA greater than or equal to 10,000 copies/mL at screening, OR b. Two consecutive and rising AdV viremia DNA results of greater than or equal to1,000 copies/mL at screening, AND i. has absolute lymphocyte count <180/mm3, OR ii. has received T cell depletion. 3. Males and females of childbearing potential who engage in heterosexual intercourse must agree to use contraception and refrain from donating sperm or eggs for at least 90 days after treatment completion. 4. Willing and able to provide signed informed consent. 5. Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.
Treatment
Childrens Hospital Colorado
Vanessa Fabrizio, MD, MS
Protocol Number: 22-0182
More information available at ClinicalTrials.gov: NCT05179057
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