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Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant

Primary Purpose

Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALVR106
Placebo
Sponsored by
AlloVir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Viral Infections focused on measuring Respiratory virus, Hematopoietic Cell Transplant, Upper Respiratory Tract Infection, Bone Marrow Transplant, Human Metapneumovirus Infection, Parainfluenza, Respiratory Syncytial Virus (RSV), Multi-virus specific T cells (VST)

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergone allogeneic, autologous, or cord blood stem cell transplantation at least 21 days prior to randomization
  • Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
  • Diagnosis of Upper Respiratory Tract Infection

Exclusion Criteria:

  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
  • Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days
  • Proven or suspected infection by novel coronavirus disease 2019 (COVID-19) within 28 days
  • Evidence of Grade >2 acute graft versus host disease (GVHD)
  • Receipt of another investigational antiviral treatment within 28 days
  • Donor lymphocyte infusion or other T cell therapies performed <21 days prior to randomization

Sites / Locations

  • Scottsdale Healthcare Hospitals DBA HonorHealthRecruiting
  • City of HopeRecruiting
  • University of Florida - Division of Hematology & OncologyRecruiting
  • University of Miami - Sylvester Cancer CenterRecruiting
  • Northside HospitalRecruiting
  • University of IowaRecruiting
  • University of Kansas Cancer CenterRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • University of North Carolina - Lineberger Comprehensive Cancer CenterRecruiting
  • Duke University Medical CenterRecruiting
  • Wake ForestRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • University of Oklahoma - Health Science CenterRecruiting
  • Medical University of South CarolinaRecruiting
  • Vanderbilt University Cancer CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • MD AndersonRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

ALVR106

Arm Description

Placebo, visually identical to ALVR106

ALVR106, visually identical to placebo

Outcomes

Primary Outcome Measures

Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests
Number (%) of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug and number (%) of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0)
Change in viral load (Part B)
Change from Baseline in viral load as measured by quantitative PCR of nasal swab

Secondary Outcome Measures

Change in viral load
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Progression from URTI to LRTI
Proportion of patients with progression to LRTI
Identify the recommended Phase 2 (RP2D) (Part A)

Full Information

First Posted
June 7, 2021
Last Updated
April 13, 2022
Sponsor
AlloVir
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1. Study Identification

Unique Protocol Identification Number
NCT04933968
Brief Title
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant
Official Title
Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 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 ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT)
Detailed Description
The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT patients suffering from infection with any of the four targeted viruses (RSV, influenza, hMPV, and/or PIV) will be safe and demonstrate shorter time to resolution of the respiratory viral infection (as measured by resolution of symptoms and viral load clearance in nasal swab) compared to patients treated with placebo. This trial will consist of two parts: Part A - Dose Escalation in Patients with Upper Respiratory Tract Infections (URTI) at High-Risk of Progression to Lower Respiratory Tract Infections (LRTI) Part B - Recommended Phase 2 Dose (RP2D) cohort expansion in patients with URTIs at high-risk of progression to LRTIs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection, Influenza Infection
Keywords
Respiratory virus, Hematopoietic Cell Transplant, Upper Respiratory Tract Infection, Bone Marrow Transplant, Human Metapneumovirus Infection, Parainfluenza, Respiratory Syncytial Virus (RSV), Multi-virus specific T cells (VST)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, visually identical to ALVR106
Arm Title
ALVR106
Arm Type
Active Comparator
Arm Description
ALVR106, visually identical to placebo
Intervention Type
Biological
Intervention Name(s)
ALVR106
Intervention Description
Infusion, visually identical to placebo
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Infusion, visually identical to ALVR106
Primary Outcome Measure Information:
Title
Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests
Description
Number (%) of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug and number (%) of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0)
Time Frame
Up to Day 365
Title
Change in viral load (Part B)
Description
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change in viral load
Description
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Time Frame
Up to Month 6
Title
Progression from URTI to LRTI
Description
Proportion of patients with progression to LRTI
Time Frame
Day 10, Day 28
Title
Identify the recommended Phase 2 (RP2D) (Part A)
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergone allogeneic, autologous, or cord blood stem cell transplantation at least 21 days prior to randomization Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV) Diagnosis of Upper Respiratory Tract Infection Exclusion Criteria: Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days Proven or suspected infection by novel coronavirus disease 2019 (COVID-19) within 28 days Evidence of Grade >2 acute graft versus host disease (GVHD) Receipt of another investigational antiviral treatment within 28 days Donor lymphocyte infusion or other T cell therapies performed <21 days prior to randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Wheeler
Phone
833.409.2281
Email
Clinicaltrials@allovir.com
Facility Information:
Facility Name
Scottsdale Healthcare Hospitals DBA HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida - Division of Hematology & Oncology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami - Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64116.
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
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina - Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma - Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73019
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
31004020
Citation
Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
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Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant

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