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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
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
...and 11 more locations
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
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.
Time frame: Day 1 up to 12 months
Change in Viral Load From Baseline to Day 28 (Part B)
Change from Baseline in viral load as measured by quantitative PCR of nasal swab
Time frame: Baseline and Day 28 (Part B)
Identify the Recommended Phase 2 Dose (RP2D) (Part A)
The RP2D was to be determined after the maximum tolerated dose was reached in Part A.
Time frame: Day 1 up to 12 months
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
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.
Time frame: Baseline and Day 28
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B)
Time frame: 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
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