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

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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

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maninder Singh
msclinic@stanford.edu