Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
- Conditions
- Respiratory Tract Viral InfectionsHuman Metapneumovirus (hMPV) InfectionRespiratory Syncytial Viral (RSV) InfectionInfluenza InfectionParainfluenza (PIV) Infection
- Interventions
- Biological: PlaceboBiological: ALVR106
- Registration Number
- NCT04933968
- Lead Sponsor
- AlloVir
- 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) and solid organ transplant (SOT).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, visually identical to ALVR106 ALVR106 ALVR106 ALVR106, visually identical to placebo
- Primary Outcome Measures
Name Time Method Change in Viral Load From Baseline to Day 28 (Part B) Baseline and Day 28 (Part B) Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B) Day 1 up to 12 months Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A) 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.
Identify the Recommended Phase 2 Dose (RP2D) (Part A) Day 1 up to 12 months The RP2D was to be determined after the maximum tolerated dose was reached in Part A.
Percentage Reduction in Viral Load From Baseline to Month 6 (Part B) Day 1 and Month 6
Trial Locations
- Locations (21)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Froedtert Hospital and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of North Carolina - Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Vanderbilt University Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Florida - Division of Hematology & Oncology
🇺🇸Gainesville, Florida, United States
City of Hope
🇺🇸Duarte, California, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
MD Anderson
🇺🇸Houston, Texas, United States
University of Miami - Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Scottsdale Healthcare Hospitals DBA HonorHealth
🇺🇸Scottsdale, Arizona, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States