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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).
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.
Age
17 - 75 years
Sex
ALL
Healthy Volunteers
No
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States
City of Hope
Duarte, California, United States
University of Florida - Division of Hematology & Oncology
Gainesville, Florida, United States
University of Miami - Sylvester Cancer Center
Miami, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Start Date
March 21, 2022
Primary Completion Date
January 31, 2024
Completion Date
January 31, 2024
Last Updated
June 6, 2024
17
ACTUAL participants
ALVR106
BIOLOGICAL
Placebo
BIOLOGICAL
Lead Sponsor
AlloVir
Data Source & Attribution
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