Clinical Trials Directory

Trials / Terminated

TerminatedNCT04933968

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

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

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
17 (actual)
Sponsor
AlloVir · Industry
Sex
All
Age
17 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALALVR106Infusion, visually identical to placebo
BIOLOGICALPlaceboInfusion, visually identical to ALVR106

Timeline

Start date
2022-03-21
Primary completion
2024-01-31
Completion
2024-01-31
First posted
2021-06-22
Last updated
2024-06-06
Results posted
2024-06-06

Locations

21 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04933968. Inclusion in this directory is not an endorsement.