Clinical Trial 21606

Study 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

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)

Objective

Part A (Does Escalation): Primary Objective: The primary objective of Part A is to determine the safety and tolerability of ascending doses of ALVR106 when administered to adult patients with high-risk upper respiratory tract infections (URTIs) caused by RSV, influenza, hMPV, and/or PIV following HCT. Secondary Objectives: To identify the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALVR106 in patients with URTIs; To characterize the individual patient antiviral response as measured by change in viral load in nasal swab from baseline through Day 28 following the patient s first ALVR106 infusion; To characterize the antiviral immunity as measured by detection of anti-RSV, hMPV, PIV, and/or influenza-specific T cells up to Day 28 and Day 60 following the patient s first ALVR106 infusion. Part B (RP2D) Cohort Expansion: Primary Objective: The primary objective of Part B is to determine the antiviral activity of the RP2D of ALVR106, as compared to placebo, when administered to adult patients with high-risk URTIs caused by RSV, influenza, hMPV, and/or PIV following HCT. Secondary Objectives: To determine the safety and tolerability of the RP2D of ALVR106 when administered to adult patients with high-risk URTIs caused by RSV, influenza, hMPV, and/or PIV following HCT; To characterize the individual patient antiviral response as measured by the percent reduction in viral load in nasal swab and a reduction in clinical signs and symptoms from baseline through Day 28, Day 60, Day 90, and Month 6 following the patient s first ALVR106 infusion; To characterize the antiviral immunity as measured by detection of anti-RSV, hMPV, PIV, and/or influenza-specific T cells up to Day 28 and Day 60 following the patient s first ALVR106 infusion; To determine the proportion of patients with progression from URTI to LRTI as defined by new onset LRTI symptoms (eg, shortness of breath, fever, fatigue, coughing, chest discomfort, production of mucus, coarse crackles) and either a decrease in FEV1 of >25%, a sustained oxygen saturation <92%, or new findings on chest X-rays and/or CT scans suggestive of pneumonitis or bronchiolitis obliterans with organizing pneumonia.