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Virus Therapy

ALVR106 for Respiratory Viral Infection

Phase 1 & 2
Waitlist Available
Research Sponsored by AlloVir
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergone allogeneic, autologous, or cord blood stem cell transplantation at least 21 days prior to randomization
Diagnosis of Upper Respiratory Tract Infection
Must not have
Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day)
Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies within 28 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to 12 months

Summary

This trial is testing a new cell therapy that targets four respiratory viruses in people who have had a hematopoietic cell transplant.

Who is the study for?
This trial is for people who've had a stem cell transplant at least 21 days ago and are now dealing with respiratory viral infections like RSV, flu, hMPV, or PIV. It's not open to those who recently received certain immune-targeting drugs, have COVID-19 symptoms, took another experimental antiviral drug in the last month, are experiencing severe graft versus host disease (GVHD), or had T cell therapies or high-dose steroids recently.
What is being tested?
The study tests ALVR106 against a placebo. ALVR106 is an innovative T cell therapy designed to fight four common respiratory viruses following a hematopoietic cell transplant. Participants will be randomly assigned to receive either this new treatment or a placebo for comparison.
What are the potential side effects?
While specific side effects of ALVR106 aren't listed here, similar treatments can cause reactions where the infusion occurs, general discomforts like fatigue and headaches, as well as potential immune system complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You currently have an infection in your nose, throat, or sinuses.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have received another experimental antiviral treatment within the past 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Viral Load From Baseline to Day 28 (Part B)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A)
Secondary study objectives
Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A)
Identify the Recommended Phase 2 Dose (RP2D) (Part A)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ALVR106Active Control1 Intervention
ALVR106, visually identical to placebo
Group II: PlaceboPlacebo Group1 Intervention
Placebo, visually identical to ALVR106

Find a Location

Who is running the clinical trial?

AlloVirLead Sponsor
11 Previous Clinical Trials
809 Total Patients Enrolled

Media Library

ALVR106 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04933968 — Phase 1 & 2
Respiratory Syncytial Virus Infection Research Study Groups: Placebo, ALVR106
Respiratory Syncytial Virus Infection Clinical Trial 2023: ALVR106 Highlights & Side Effects. Trial Name: NCT04933968 — Phase 1 & 2
ALVR106 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04933968 — Phase 1 & 2
~5 spots leftby Jan 2026
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