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Adenovirus InfectionPhase 2/3PreventNCT05305040

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

A Phase 2/3 study testing Posoleucel (ALVR105) in people with Adenovirus Infection and BK Virus Infection, run by AlloVir at 88 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Posoleucel (ALVR105)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
451 participants
Where
88 sitesin 10 countries
Study dates
24 Mar 2022to 30 Jan 2024
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

88 sites in 10 countries.

88 sites in 10 countries

United States35 sites

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham Children's of Alabama

    Birmingham, Alabama, 35233

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Carolinas Medical Center/Levine

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

  • City of Hope

    Duarte, California, 91010

  • University of Florida (UF) - Gainesville

    Gainesville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Indiana University Hospital Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University School of Medicine - Yale Cancer Center

    New Haven, Connecticut, 06520

  • Columbia University

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Utah/Primary Childrens Hospital

    Salt Lake City, Utah, 84113

  • University of California San Francisco - Benioff Children's Hospital

    San Francisco, California, 94143

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook University Hospital Cancer Center

    Stony Brook, New York, 11794

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Childrens National Health System

    Washington D.C., District of Columbia, 20010

Other trials in United States

Turkey (Türkiye)9 sites

  • Acibadem Adana Hospital

    Adana

  • Baskent Adana Hospital

    Adana

  • Ankara Onkoloji Egitim Ve Arastirma Hastanesi

    Ankara

  • Ankara University Hospital

    Ankara

  • Gazi University Medical Faculty Hospital

    Ankara

  • Medical Park Hospital

    Antalya

  • Ege University Medical Faculty

    Izmir

  • Anadolu Medical Center Hospital

    Kocaeli

  • Inonu University Turgut Özal Medical Centre

    Malatya

Other trials in Turkey (Türkiye)

France7 sites

  • Centre Hospitalier Regional Universitaire de Lille

    Lille

  • CHU de Nantes

    Nantes

  • AP-HP Hopital Saint-Louis

    Paris

  • Hopital Saint Antoine

    Paris

  • Hopital Universitaire Robert Debre

    Paris

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • IUCT-Oncopole

    Toulouse

Other trials in France

Italy7 sites

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

  • Ospedale San Raffaele

    Milan

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia

  • IRCSS Ospedale Pediatrico Bambino Gesu

    Roma

  • University of Sacred Heart Policlinico A. Gemelli

    Rome

  • Humanitas Cancer Center

    Rozzano

  • Azienda Ospedaliera Universitaria Integrata Verona (AOUI)

    Verona

Other trials in Italy

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide

  • Austin Health

    Heidelberg

  • Royal Brisbane and Women's Hospital

    Herston

  • Royal Melbourne Hospital

    Parkville

  • Queensland Children's Hospital

    South Brisbane

  • Westmead Hospital

    Westmead

Other trials in Australia

Canada6 sites

  • Alberta Children's Hospital

    Calgary

  • Cellular Therapy Program - CHU Sainte-Justine (McGill)

    Montreal

  • Hopital Maisonneve Rosemont

    Montreal

  • The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program

    Toronto

  • UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center

    Toronto

  • Leukemia/ BMT Program of British Columbia - Vancouver General Hospital

    Vancouver

Other trials in Canada

South Korea6 sites

  • Pusan National University Hospital

    Busan

  • Chonnam National University Hwasun Hospital

    Hwasun

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul St. Mary's Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

United Kingdom5 sites

  • Bristol Haematology and Oncology Centre

    Bristol

  • University Hospitals Bristol - Bristol Hospital for Children

    Bristol

  • Addenbrooke's Hospital

    Cambridge

  • Queen Elizabeth University Hospital - Glasgow

    Glasgow

  • Great Ormond Street Hospital for Children

    London

Other trials in United Kingdom

Spain4 sites

  • Institut Catala d'Oncologia

    Barcelona

  • Hospital General Universitario Gregorio Maranon

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia

Other trials in Spain

Belgium3 sites

  • A.Z. Sint-Jan Brugge Oostende AV

    Bruges

  • Institut Jules Bordet and the Childrens Hospital

    Brussels

  • University Hospital Gasthuisberg and Leuven

    Leuven

Other trials in Belgium

About this study

Official title: 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

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.

Read the 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.

Being tested
Posoleucel (ALVR105), Placebo
Keywords
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M, Virus-specific T cells (VSTs), Cytotoxic T Lymphocytes (CTLs)
Medical subject headings
Adenoviridae Infections, Cytomegalovirus Infections, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posoleucel (ALVR105)Biological

    Also called Viralym-M

    Administered as 2-4 milliliter infusion, visually identical to placebo

  • PlaceboBiological

    Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Study groups in NCT05305040
Study groupRoleWhat they receive
Posoleucel (ALVR105)ExperimentalAdministered as 2-4 milliliter infusion, visually identical to placebo
Receives: Biological: Posoleucel (ALVR105)
PlaceboPlacebo comparatorAdministered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Through Week 14

Secondary outcomes (2)

  1. 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.

    Measured: Through Week 26

  2. 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.

    Measured: Through Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start24 Mar 2022
  3. Primary completion30 Jan 2024
  4. Study completion30 Jan 2024

Why it stopped: Study discontinued as DSMB determined it was futile. No safety concerns were noted.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305040
Sponsor's protocol ID
P-105-202 Phase 3
Acronym
Prevent
Status last verified
Apr 2024
First submitted
22 Mar 2022
Last updated
16 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.

  • Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.

    PubMed 28783452

  • Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.

    PubMed 38597860

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Posoleucel (ALVR105) in people with Adenovirus Infection and BK Virus Infection, run by AlloVir at 88 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Turkey (Türkiye), France, Italy, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14 (time frame: Through Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05305040, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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