RecruitingPhase 2NCT05248230

4D-710 in Adult Patients With Cystic Fibrosis

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults With Cystic Fibrosis

Sponsor

4D Molecular Therapeutics

Enrollment

30 participants

Start Date

Mar 29, 2022

Study Type

INTERVENTIONAL

Conditions

Cystic Fibrosis Lung

Summary

This is a Phase 1/2 multicenter, open-label, single dose trial of 4D-710 investigational gene therapy in adults with cystic fibrosis.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called 4D-710 for people with cystic fibrosis lung. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL4D-710

4D-710 is an adeno-associated virus (AAV) gene therapy comprised of an AAV capsid variant (4D-A101) carrying a transgene cassette encoding human cystic fibrosis transmembrane conductance regulator with a deletion in the regulatory domain (CFTRΔR).

Locations(20)

University of Alabama Child Health Research Unit

Birmingham, Alabama, United States

The University of Arizona

Tucson, Arizona, United States

University of California San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of Miami Hospital

Miami, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Penn State Health

Hershey, Pennsylvania, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05248230

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