Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (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 3

This is a Phase 3 study to evaluate posoleucel (ALVR105, 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.

2022-03-21

2024-01-31

2024-01-31

Terminated

Early phase I

378

Key Inclusion Criteria: * Any age at the day of screening visit. * No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV * Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing * 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 * Matched or Mismatched unrelated donor * Use of umbilical cord blood as stem cell source * Ex vivo graft manipulation resulting in T cell depletion * Received anti-thymocyte globulin or alemtuzumab (Campath-1H) 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 Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies * Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>1.0 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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2024-02-02