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

Phase 2

Terminated

Conditions: Epstein-Barr Virus Infections
Human Herpes Virus-6 Infection
JC Virus Infection
Cytomegalovirus Infections
Adenovirus Infection
BK Virus Infection

Brief Summary: 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.

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, 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus	Through Week 14	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.
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26	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.

Locations (88): University of Alabama at Birmingham Children's of Alabama
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Birmingham, Alabama, United States
Honor Health Research Institute
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Scottsdale, Arizona, United States
City of Hope
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Duarte, California, United States
University of California, Los Angeles (UCLA)
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Los Angeles, California, United States
Stanford University
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Palo Alto, California, United States
University of California San Francisco - Benioff Children's Hospital
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San Francisco, California, United States
University of Colorado Hospital
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Aurora, Colorado, United States
Yale University School of Medicine - Yale Cancer Center
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New Haven, Connecticut, United States
Childrens National Health System
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Washington, District of Columbia, United States
University of Florida (UF) - Gainesville
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Gainesville, Florida, United States
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University of Alabama at Birmingham Children's of Alabama
🇺🇸Birmingham, Alabama, United States