AchromoPhage for Cystic Fibrosis

Not yet recruiting at 1 trial location

Overseen By Kailey Hughes Kramer - Director, Translational Research Unit, PhD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ghady Haidar

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if a new treatment called AchromoPhage is safe and well tolerated in adults with cystic fibrosis (CF) who have long-term lung infections caused by Achromobacter bacteria. AchromoPhage is a mixture of four naturally occurring viruses, called phages, that are designed to target and kill Achromobacter.

This study will include 12 participants. People will be randomly assigned to one of three groups to receive AchromoPhage in different ways: by inhalation only, by intravenous (IV) infusion only, or by inhalation followed by IV infusion.

Participants will:

* Receive the study drug during clinic visits over a period of three weeks.

* Provide blood, sputum, nasal, and oral samples so researchers can measure how the phages move through the body, how long they stay, and whether the body develops a response against them.

* Complete breathing tests and quality-of-life questionnaires.

The main question this study will answer is whether AchromoPhage causes any serious or treatment-limiting side effects in the first 42 days after dosing. Researchers will also look at changes in lung function, quality of life, phage levels in the body, and how the treatment affects Achromobacter and other bacteria in the lungs.

The study is being run at the University of Pittsburgh (Pittsburgh, PA) and the University of California San Diego (San Diego, CA).

Who Is on the Research Team?

Ghady Haidar, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with cystic fibrosis who have chronic lung infections caused by Achromobacter bacteria. Participants will be divided into three groups to receive a new treatment called AchromoPhage through inhalation, IV infusion, or both.

Inclusion Criteria

I can and will give my consent, or my legal guardian can and will on my behalf.

I weigh at least 40 kg.

Willingness to comply with study procedures

Exclusion Criteria

I haven't been hospitalized or needed serious medical treatment in the last 30 days.

I have not had a respiratory illness or viral infection in the last 30 days.

Absolute neutrophil count < 1000 cells/uL

What Are the Treatments Tested in This Trial?

Interventions

• AchromoPhage

Trial Overview AchromoPhage, a mix of viruses targeting Achromobacter, is being tested for safety and effectiveness in CF patients with chronic lung infections. The study involves clinic visits over three weeks for dosing and monitoring through samples and questionnaires.

How Is the Trial Designed?

Group I: Intravenous Alone Arm Experimental Treatment 1 Intervention

Participants will receive a single weekly administration of AchromoPhage via the intravenous route. Each weekly administration consists of escalating intravenous doses of the cocktail. * Day 0 (visit 1, 1st week): 4×10⁷ total PFU * Day 7 (visit 2, 2nd week): 4×10⁸ total PFU * Day 14 (visit 3, 3rd week): 4×10⁹ total PFU

Group II: Inhaled Alone Arm Experimental Treatment 1 Intervention

Participants will receive a single weekly administration of AchromoPhage via the inhaled route for a total of three administrations. Each weekly administration consists of escalating inhaled doses of the cocktail: * Day 0 (visit 1, 1st week): 4×10⁷ total PFU * Day 7 (visit 2, 2nd week): 4×10⁸ total PFU * Day 14 (visit 3, 3rd week): 4×10⁹ total PFU

Group III: Combination Inhaled + Intravenous Arm Experimental Treatment 1 Intervention

Participants will receive a single weekly administration of AchromoPhage, which will consist of an inhaled dose followed by an intravenous dose given during the same study visit, with a 60-minute wait between doses. Weekly dose escalation will apply to each route, resulting in a total dose that is double that of the single route arms, as follows: * Day 0 (visit 1, 1st week): 8×10⁷ totalPFU \[i.e. 4×10⁷ total PFU inhaled, followed by a 60-minute wait, then 4×10⁷ total PFU intravenous\] * Day 7 (visit 2, 2nd week):8×10⁸ total PFU \[i.e. 4×10⁸ total PFU inhaled, followed by a 60-minute wait, then 4×10⁸ total PFU intravenous\] * Day 14 (visit 3, 3rd week): 8×10⁹ total PFU \[i.e. 4×10⁹ total PFU inhaled, followed by a 60-minute wait, then 4×10⁹ total PFU intravenous\]

Who Is Running the Clinical Trial?

Ghady Haidar

Lead Sponsor

Trials

1

Recruited

140+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+