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Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

Primary Purpose

BK Virus Infection, Hemorrhagic Cystitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Posoleucel (ALVR105)
Placebo
Sponsored by
AlloVir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BK Virus Infection focused on measuring Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

Participants must meet all of the following criteria in order to be eligible to participate in the study:

  • Male or female ≥1 year of age.
  • Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
  • Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.

  • Diagnosed with HC based on the following criteria (all 3 criteria must be met):

    1. Clinical signs and/or symptoms of cystitis.
    2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
    3. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
  • At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.

Key Exclusion Criteria

Participants who meet any of the following criteria will be excluded from participation in the study:

  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
  • Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
  • Evidence of active Grade >2 acute graft versus host disease (GVHD).
  • Uncontrolled or progressive bacterial or fungal infections.
  • Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
  • Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
  • Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
  • Pregnant or lactating or planning to become pregnant.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • City of Hope National Medical CenterRecruiting
  • Children's Hospital of Los AngelesRecruiting
  • Yale University School of Medicine - Yale Cancer CenterRecruiting
  • Children's National Medical CenterRecruiting
  • University of MiamiRecruiting
  • MoffittRecruiting
  • Northside HospitalRecruiting
  • Northwestern Memorial HospitalRecruiting
  • University of Kansas Cancer CenterRecruiting
  • Johns Hopkins MedicineRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • Massachusetts General HospitalRecruiting
  • University of MinnesotaRecruiting
  • Children's Mercy Hospital - Kansas CityRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Ohio State University Medical Center (OSUMC)Recruiting
  • Oregon Health & Science UniversityRecruiting
  • Children's Hospital of Philadelphia (CHOP)Recruiting
  • The University of Texas Southwestern Medical CenterRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • Froedtert Hospital and the Medical College of WisconsinRecruiting
  • CHU de Lille - Hopital Claude HuriezRecruiting
  • CHU de Nantes - Hôtel-DieuRecruiting
  • AP-HP Hopital Saint-LouisRecruiting
  • HCL Centre Hospitalier Lyon SudRecruiting
  • IUCT-OncopoleRecruiting
  • Azienda Ospedaliero-Universitaria CareggiRecruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di MilanoRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Ospedale Pediatrico Bambino GesùRecruiting
  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRecruiting
  • Istituto Clinico HumanitasRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo TrentoRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Pusan National University HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Seoul St. Mary's Hospital, The Catholic University of KoreaRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Hospital Clinic BarcelonaRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Karolinska University HospitalRecruiting
  • University Hospitals Bristol NHS Foundation TrustRecruiting
  • Queen Elizabeth University Hospital - GlasgowRecruiting
  • Great Ormond Street Hospital for ChildrenRecruiting
  • Hammersmith HospitalRecruiting
  • The Royal Marsden NHS Foundation TrustRecruiting
  • University College London HospitalRecruiting
  • Nottingham University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Posoleucel (ALVR105)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time until urine is visually clear of hematuria

Secondary Outcome Measures

Time until bladder pain is resolved
Days in the hospital for any reason
Time to resolution for target all viruses
Average daily bladder/lower abdominal pain
Incidence and severity of acute graft versus host disease and cytokine release syndrome

Full Information

First Posted
May 12, 2020
Last Updated
January 6, 2023
Sponsor
AlloVir
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1. Study Identification

Unique Protocol Identification Number
NCT04390113
Brief Title
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
Official Title
Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlloVir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to evaluate posoleucel (ALVR105); 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
The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Virus Infection, Hemorrhagic Cystitis
Keywords
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Arm Title
Posoleucel (ALVR105)
Arm Type
Experimental
Arm Description
Administered as 2-4 milliliter infusion, visually identical to placebo
Intervention Type
Biological
Intervention Name(s)
Posoleucel (ALVR105)
Intervention Description
Administered as 2-4 milliliter infusion, visually identical to placebo
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Primary Outcome Measure Information:
Title
Time until urine is visually clear of hematuria
Time Frame
Until event occurrence through week 24
Secondary Outcome Measure Information:
Title
Time until bladder pain is resolved
Time Frame
Until event occurrence through week 24
Title
Days in the hospital for any reason
Time Frame
Until event occurrence through week 24
Title
Time to resolution for target all viruses
Time Frame
Until event occurrence through week 24
Title
Average daily bladder/lower abdominal pain
Time Frame
Until event occurrence through week 6
Title
Incidence and severity of acute graft versus host disease and cytokine release syndrome
Time Frame
Until event occurance through week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Participants must meet all of the following criteria in order to be eligible to participate in the study: Male or female ≥1 year of age. Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization. Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization. Diagnosed with HC based on the following criteria (all 3 criteria must be met): Clinical signs and/or symptoms of cystitis. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6). At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available. Key Exclusion Criteria Participants who meet any of the following criteria will be excluded from participation in the study: Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent). Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization. Evidence of active Grade >2 acute graft versus host disease (GVHD). Uncontrolled or progressive bacterial or fungal infections. Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105). Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder. Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy. Pregnant or lactating or planning to become pregnant. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle Herbert
Phone
+1 833-409-2281
Email
ClinicalTrials@allovir.com
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University School of Medicine - Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Mercy Hospital - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio State University Medical Center (OSUMC)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia (CHOP)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
CHU de Lille - Hopital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes - Hôtel-Dieu
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hopital Saint-Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
HCL Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Name
IUCT-Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Clinic Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital - Glasgow
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital for Children
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham University Hospitals
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28783452
Citation
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.
Results Reference
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Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

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