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

Phase 2

Completed

• Conditions: Cytomegalovirus Infections; Human Herpes Virus-6 Infection; Adenovirus Infection; Epstein-Barr Virus Infections; BK Virus Infection; JC Virus Infection
• Interventions: Biological: Posoleucel (ALVR105)

• Registration Number: NCT04693637
• Lead Sponsor: AlloVir

Brief Summary

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.

Detailed Description

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, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2021-01-15
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Results First Submitted: 2023-12-19
• Results First Submitted QC: 2024-04-11
• Status Verified: 2024-05
• Results First Posted: 2024-05-07
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Posoleucel (ALVR105)	Posoleucel (ALVR105)	Administered as 2-4 milliliter infusion

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease	Through Week 14	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV)	through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)	Through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV)	Through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6)	Through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV	Through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 14 and Week 26 (6 endpoints each at Week 14 and Week 26).
Rates of Overall and Non-Relapse Mortality	Through Week 52	The number of mortality events due to non-relapse causes through Week 52.
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease	Through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 26.
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV)	Through Week 26	The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV from each individual virus through Week 26 (6 endpoints each at Week 26).

Trial Locations

Locations (16)

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

University of Kansas Hospital; 🇺🇸 Westwood, Kansas, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Stony Brook University Hospital Cancer Center; 🇺🇸 Stony Brook, New York, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Children's Medical Center Dallas; 🇺🇸 Dallas, Texas, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Childrens National Medical Center; 🇺🇸 Northwest Rectangle, District of Columbia, United States

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States