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

June 4, 2024 updated by: AlloVir

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 and Solid Organ Transplant

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) and solid organ transplant (SOT).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT or SOT 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 is Dose Escalation and Part B is Cohort Expansion.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Healthcare Hospitals DBA HonorHealth
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida - Division of Hematology & Oncology
      • Miami, Florida, United States, 33136
        • University of Miami - Sylvester Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 64116.
        • University of Kansas Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • Buffalo, New York, United States, 14203
        • Roswell Park Comprehensive Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Lineberger Comprehensive Cancer Center
      • Durham, North Carolina, United States, 27708
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • MD Anderson
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
  • Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
  • Diagnosis of Upper or mild Lower Respiratory Tract Infection

Exclusion Criteria:

  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
  • Infection by novel coronavirus disease 2019 (COVID-19)
  • For HCT patients, evidence of Grade >2 GVHD; and for SOT patients, any history or evidence of GVHD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo, visually identical to ALVR106
Biological: Placebo
Infusion, visually identical to ALVR106
Active Comparator: ALVR106
ALVR106, visually identical to placebo
Biological: ALVR106
Infusion, visually identical to placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Time Frame: Day 1 up to 12 months
A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Day 1 up to 12 months
Change in Viral Load From Baseline to Day 28 (Part B)
Time Frame: Baseline and Day 28 (Part B)
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Baseline and Day 28 (Part B)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the Recommended Phase 2 Dose (RP2D) (Part A)
Time Frame: Day 1 up to 12 months
The RP2D was to be determined after the maximum tolerated dose was reached in Part A.
Day 1 up to 12 months
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
Time Frame: Baseline and Day 28
Viral load was measured by quantitative polymerase chain reaction (PCR) of nasal swab specimens. The cycle threshold value categorizes the concentration of viral genetic material in a participant's swab specimen, and the cycle threshold value represents the number of PCR cycles required to amplify the viral genetic material (as measured by fluorescence) to a detectable level that is distinguishable from baseline fluorescence, providing an estimate of viral load. Lower cycle threshold values indicate higher viral load and high values indicate lower viral load. A positive change from baseline indicates a decrease in the viral load. The baseline measurement was from a pre-dose nasal swab.
Baseline and Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)
Time Frame: Day 1 up to 12 months
Day 1 up to 12 months
Percentage Reduction in Viral Load From Baseline to Month 6 (Part B)
Time Frame: Day 1 and Month 6
Day 1 and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlloVir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-106-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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