Page Title
Clinical Trial Finder
Genetic Therapy Enrolling
Study to evaluate KB407 in adults with cystic fibrosis (Krystal Biotech KB407-02)
This study will evaluate safety and tolerability of ascending doses of nebulized KB407, a gene therapy intended to deliver a new, correct copy of the CFTR gene (DNA) to cells in adults with cystic fibrosis.
This is cohort 3 of a phase 1 study, with cohorts 1 and 2 already complete. All study participants will receive four administrations of the nebulized study drug KB407. Researchers will measure safety and tolerability by monitoring for changes from baseline in a participant’s physical exam, vital signs, ECG, and laboratory test results.
This study may require exams, blood draws, lung function tests, a bronchoscopy, and/or other measurements.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
This study is primarily enrolling participants that are not using CFTR modulators.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
3 months -
Number of Study Visits:
10
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
Krystal Biotech -
Study Drugs:
Study Sites
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Closed to Enrollment
California
Children's Hospital of Los Angeles, Los Angeles, CA 90027
-
Enrolling
Florida
University of Florida, Gainesville, FL 32610
Contact
Alexa Smith
Phone: +1
Email: alexa.howell@ufl.edu
-
Enrolling
Massachusetts
Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling Soon
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling Soon
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
Enrolling Soon
New Jersey
Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ 08903
Contact
Sheila Redding
Phone: +1
Email: sr1238@rwjms.rutgers.edu
-
Enrolling
New York
Lenox Hill Cystic Fibrosis Center, New York, NY 10028
Contact
Teresa Demarco
Phone: +1 (212) 434-4790
Email: Tdemarco3@northwell.edu
-
Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
-
Enrolling
North Carolina
Atrium Health Wake Forest Baptist, Winston-Salem, NC 27157
Contact
Anna Pippins
Phone: +1 (336) 713-9184
Email: anna.pippins@advocatehealth.org
-
Enrolling Soon
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
This study is primarily enrolling participants that are not using CFTR modulators.
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