Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant

P-105-202 Phase 2

This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

2021-01-15

2023-01-19

2023-01-19

Completed

Early phase I

26

Key Inclusion Criteria * ≥1 year of age at the day of screening visit. * Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening * Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment * Meet one or more of the following criteria at the time of randomization: * Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR * Haploidentical donor * Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR * Use of umbilical cord blood as stem cell source * Ex vivo graft manipulation resulting in T cell depletion * Lymphocyte Count \<180/mm3 and/or cluster of differentiation 4 (CD4) Count \<50/mm3 Key Exclusion Criteria: * History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization * Evidence of active Grade \>2 acute GVHD * Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections * Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies * Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 mg/kg/day) within 24 hours prior to dosing * Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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2024-05-09