ALVR106 in Treatment of Respiratory Viral Infections After Hematopoietic Stem Cell Transplant - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called ALVR106 (study drug) is a safe and effective treatment for people who have viral lung infections after receiving a bone marrow transplant. We also want to determine what dose level of the drug works best.

What is the Condition Being Studied?

Viral lung infections following bone marrow transplant

Who Can Participate in the Study?

Adults ages 18-75 who:
- Have a viral infection of the lungs (contact study team for eligible viral infections)
- Received a bone marrow transplant in the past 21 days
- Have not had a suspected COVID-19 infection in the last 28 days

For more information about who can join this study, please contact the study team at surya.nagesh@duke.edu.

Age Group
Adults, Children

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to get either the study drug or placebo (inactive substance)
- Have physical exams
- Have blood draws
- Have breathing tests
- Get a chest X-Ray or CT scan
- Have heart scans (ECG)

Depending on when you join the study, you will participate in Part A or Part B. In Part A, 4 different doses of the study drug will be tested. In Part B, only the most effective dose determined by Part A will be used.

Your participation in this study will last for about 1 year.

Study Details

Full 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 Stem Cell Transplant
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00106001
NCT: NCT04933968
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698