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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05305040
Other study ID # P-105-202 Phase 3
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date March 24, 2022
Est. completion date January 30, 2024

Study information

Verified date April 2024
Source AlloVir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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 information / eligibility

Status Terminated
Enrollment 451
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Biological:
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide
Australia Austin Health Heidelberg
Australia Royal Brisbane and Women's Hospital Herston
Australia Royal Melbourne Hospital Parkville
Australia Queensland Children's Hospital South Brisbane
Australia Westmead Hospital Westmead
Belgium A.Z. Sint-Jan Brugge Oostende AV Brugge
Belgium Institut Jules Bordet and the Childrens Hospital Bruxelles
Belgium University Hospital Gasthuisberg and Leuven Leuven
Canada Alberta Children's Hospital Calgary
Canada Cellular Therapy Program - CHU Sainte-Justine (McGill) Montréal
Canada Hopital Maisonneve Rosemont Montréal
Canada The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program Toronto
Canada UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center Toronto
Canada Leukemia/ BMT Program of British Columbia - Vancouver General Hospital Vancouver
France Centre Hospitalier Regional Universitaire de Lille Lille
France CHU de Nantes Nantes
France AP-HP Hopital Saint-Louis Paris
France Hopital Saint Antoine Paris
France Hopital Universitaire Robert Debre Paris
France Centre Hospitalier Lyon Sud Pierre-Bénite
France IUCT-Oncopole Toulouse
Italy Azienda Ospedaliero-Universitaria Careggi Firenze
Italy Ospedale San Raffaele Milan
Italy Fondazione I.R.C.C.S. Policlinico San Matteo Pavia
Italy IRCSS Ospedale Pediatrico Bambino Gesu Roma
Italy University of Sacred Heart Policlinico A. Gemelli Rome
Italy Humanitas Cancer Center Rozzano
Italy Azienda Ospedaliera Universitaria Integrata Verona (AOUI) Verona
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Spain Institut Catala d'Oncologia Barcelona
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Regional Universitario de Malaga Málaga
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Turkey Acibadem Adana Hospital Adana
Turkey Baskent Adana Hospital Adana
Turkey Ankara Onkoloji Egitim Ve Arastirma Hastanesi Ankara
Turkey Ankara University Hospital Ankara
Turkey Gazi University Medical Faculty Hospital Ankara
Turkey Medical Park Hospital Antalya
Turkey Ege University Medical Faculty Izmir
Turkey Anadolu Medical Center Hospital Kocaeli
Turkey Inonu University Turgut Özal Medical Centre Malatya
United Kingdom Bristol Haematology and Oncology Centre Bristol
United Kingdom University Hospitals Bristol - Bristol Hospital for Children Bristol
United Kingdom Addenbrooke's Hospital Cambridge
United Kingdom Queen Elizabeth University Hospital - Glasgow Glasgow
United Kingdom Great Ormond Street Hospital for Children London
United States Northside Hospital Atlanta Georgia
United States University of Colorado Hospital Aurora Colorado
United States University of Maryland Baltimore Maryland
United States University of Alabama at Birmingham Children's of Alabama Birmingham Alabama
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Carolinas Medical Center/Levine Charlotte North Carolina
United States University of Virginia Charlottesville Virginia
United States Nationwide Children's Hospital Columbus Ohio
United States Children's Medical Center Dallas Dallas Texas
United States City of Hope Duarte California
United States University of Florida (UF) - Gainesville Gainesville Florida
United States Hackensack University Medical Center Hackensack New Jersey
United States Indiana University Hospital Simon Comprehensive Cancer Center Indianapolis Indiana
United States Children's Mercy Hospital Kansas City Missouri
United States University of Kansas Hospital Kansas City Kansas
United States University of California, Los Angeles (UCLA) Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Yale University School of Medicine - Yale Cancer Center New Haven Connecticut
United States Columbia University New York New York
United States Weill Cornell Medical College New York New York
United States Stanford University Palo Alto California
United States University of Pennsylvania Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah/Primary Childrens Hospital Salt Lake City Utah
United States University of California San Francisco - Benioff Children's Hospital San Francisco California
United States Honor Health Research Institute Scottsdale Arizona
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Stony Brook University Hospital Cancer Center Stony Brook New York
United States Moffitt Cancer Center Tampa Florida
United States Childrens National Health System Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
AlloVir

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Italy,  Korea, Republic of,  Spain,  Turkey,  United Kingdom, 

References & Publications (2)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Through Week 14
Secondary 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. Through Week 26
Secondary 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. Through Week 14
See also
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Not yet recruiting NCT06058858 - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
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