Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Phase 3TerminatedNCT05305040

AlloVir451 enrolled

Overview

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.

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT. There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

451

Conditions

Adenovirus Infection BK Virus Infection Cytomegalovirus Infections

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (88)

University of Alabama at Birmingham Children's of Alabama

Birmingham, Alabama, United States

Honor Health Research Institute

Scottsdale, Arizona, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14

The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).

Time frame: Through Week 14

Secondary Outcomes

Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26

The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV.

Time frame: Through Week 26

Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus

The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV.