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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

You currently have an infection in your nose, throat, or sinuses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in viral load (Part B)

Safety and Tolerability of ascending doses of ALVR106 assessed through Adverse Events and Clinical Laboratory tests

Secondary outcome measures

Change in viral load

Identify the recommended Phase 2 (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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AlloVirLead Sponsor

11 Previous Clinical Trials

739 Total Patients Enrolled

Media Library

ALVR106 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04933968 — Phase 1 & 2

Respiratory Viral Infection Research Study Groups: Placebo, ALVR106

Respiratory Viral 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively seeking out new participants?

"As indicated by clinicaltrials.gov, this trial is currently recruiting participants; it was first posted on March 21st 2022 and underwent its latest update April 13th of the same year."

Answered by AI

Does the eligibility criteria for this experiment encompass people over twenty years of age?

"This clinical trial's inclusion criteria specifies that all potential participants must be over the age of 17 and younger than 75 years old."

Answered by AI

How many clinical centers are currently administering this experiment?

"These 20 sites are actively recruiting participants for this medical trial: Virginia Commonwealth University in Richmond, University of Florida - Division of Hematology & Oncology in Gainesville, and Duke University Medical Center. Additionally there exist 17 other locations."

Answered by AI

What is the participant quota for this experiment?

"For this trial to be successful, 77 participants who meet the eligibility criteria must partake in it. Potential candidates can receive enrollment information from Virginia Commonwealth University located in Richmond and the Hematology & Oncology department at the University of Florida-Gainesville."

Answered by AI

To whom is this clinical experiment suitable for participation?

"Prospective participants of this trial should demonstrate the presence of parainfluenza and be between 17-75 years old. Approximately 77 people will be accepted in total."

Answered by AI

Recent research and studies

HaematologicaJournal

Rapid Generation of Multivirus-specific T Lymphocytes for the Prevention and Treatment of Respiratory Viral Infections

Vasileiou, Spyridoula, Anne M. Turney, Manik Kuvalekar, Shivani S. Mukhi, Ayumi Watanabe, Premal Lulla, Carlos A. Ramos, et al.. 2019. “Rapid Generation of Multivirus-specific T Lymphocytes for the Prevention and Treatment of Respiratory Viral Infections”. Haematologica. Ferrata Storti Foundation (Haematologica). doi:10.3324/haematol.2018.206896.

clinicaltrials.govStudy

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

2022. "Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04933968.