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Virus Therapy

Bacteriophage Therapy for Cystic Fibrosis

Phase 1 & 2
Waitlist Available
Research Sponsored by BiomX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
Must not have
Receipt of prior bacteriophage therapy within the 6 months prior to Screening
Currently receiving treatment for allergic bronchopulmonary aspergillosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing if a new drug is safe and if it can help reduce infection in people with CF.

Who is the study for?
Adults over 18 with cystic fibrosis and chronic lung infection caused by Pseudomonas aeruginosa can join. They must be clinically stable, able to produce sputum samples, and have a certain level of lung function (FEV1 ≥ 40%). Excluded are those with severe immune issues, prior bacteriophage therapy within six months, specific ongoing treatments for other conditions, or recent changes in CF modulator therapy.
What is being tested?
The trial is testing BX004-A, a nebulized bacteriophage therapy against a placebo. The main goal is to check if it's safe and tolerable for patients. Researchers will also explore whether this treatment reduces the amount of Pseudomonas bacteria in the lungs.
What are the potential side effects?
While not specified here, common side effects from similar therapies may include respiratory symptoms like coughing or wheezing due to inhalation of the substance; allergic reactions; fatigue; and gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have cystic fibrosis with a chronic lung infection due to Pseudomonas aeruginosa and am on standard CF treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had bacteriophage therapy in the last 6 months.
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I am currently being treated for a lung fungus allergy.
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I have had severe low white blood cell counts.
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I have had a lung transplant.
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I am currently being treated for a non-tuberculous mycobacteria infection.
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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Safety and tolerability
Other study objectives
PsA burden in sputum at various timepoints

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BX004-AExperimental Treatment1 Intervention
Participants will be randomized to receive standard dose of nebulized bacteriophage
Group II: PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive nebulized placebo

Find a Location

Who is running the clinical trial?

BiomX, Inc.Lead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
Xilla Ussery, MDStudy DirectorBiomX, Inc.
Urania Rappo, MDStudy DirectorBiomX, Inc.
5 Previous Clinical Trials
749 Total Patients Enrolled

Media Library

BX004-A (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05010577 — Phase 1 & 2
Cystic Fibrosis Research Study Groups: BX004-A, Placebo
Cystic Fibrosis Clinical Trial 2023: BX004-A Highlights & Side Effects. Trial Name: NCT05010577 — Phase 1 & 2
BX004-A (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05010577 — Phase 1 & 2
~9 spots leftby Nov 2025
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