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Apr

Clinical Trial Alerts – April 2022

Cystic Fibrosis Foundation issued the following clinical trial alerts in April.

April 6, 2022

Study of 4D-710 in Adults with Cystic Fibrosis

Status: Enrolling

Description: This study will test the safety and tolerability of 4D-710, an investigational gene therapy, in adults with CF who are not eligible for or are unable to tolerate CFTR modulator therapy.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 50 to 100%

Number of Visits: 11

Length of Participation: 2 years

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05248230

April 11, 2022 (similar trials with slightly different operation)

Study to evaluate nebulized BX004-A in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (BiomX Phase 1b/2a)

Status: Enrolling

Description: This study is testing the safety and tolerability of nebulized BX004-A, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA) to find the best dose.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 6

Length of Participation: 192 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05010577

Study to evaluate nebulized BX004-A in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (BiomX Phase 1b/2a)

Status: Enrolling

Description: This study is testing the safety and tolerability of nebulized BX004-A, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA) to find the best dose.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 7

Length of Participation: 189 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT05010577


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