ALVR106 in Treatment of High-Risk Patients with Respiratory Viral Infections After HSCT or SOT

What is the Purpose of this Study?

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.
What is the Condition Being Studied?
Viral lung infections following bone marrow transplant

Who Can Participate in this 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 alexis.dalby@duke.edu.

Age Group
Both
Participating Institutions

What is Involved?

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.

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

Contacts
Hematological Malignancies, Cellular Therapy and ABMT
Protocol Number
IRB:
PRO00106001

NCT:
NCT04933968
ClinicalTrials.gov
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