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Genetic Therapy Closed to Enrollment
Study to evaluate RCT2100 in adults with cystic fibrosis who are not eligible for/or not taking CFTR modulator therapy (Part 2) (ReCode RCT2100-101 Part 2 MAD)
This study will evaluate the safety and tolerability of RCT2100, an investigational inhaled messenger RNA (mRNA), in adults with CF who are not eligible for CFTR modulator therapy or who are not able to take CFTR modulatory therapy. An mRNA therapy delivers the correct genetic instructions to cells by providing a new, functional copy of CFTR mRNA, which, it is hoped, will result in a functional CFTR protein.
Part 2 is an open-label study, meaning all participants will receive RCT2100. Study participants will receive multiple doses of the study drug. This is an ascending dose study, meaning different doses will be evaluated starting at the lowest dose, and if shown to be tolerated, moving on to the next higher dose. In this study, researchers will assess safety and tolerability by monitoring for any changes in a participant’s health.
This study may require blood draws, lung function testing, electrocardiograms, and/or other measurements.
The length of the study is either 7 months (17 study visits) or 10 months (41 study visits).
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years to 60 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants will either have mutations that are not eligible to receive CFTR modulator therapy or are no longer taking CFTR modulator therapy due to intolerance or other reasons.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
10 months -
Number of Study Visits:
41
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
ReCode Therapeutics -
Study Drugs:
Study Sites
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Closed to Enrollment
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233
-
Closed to Enrollment
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
-
Closed to Enrollment
California
University of California San Diego, La Jolla, CA 92037
-
Closed to Enrollment
California
Stanford University Medical Center, Palo Alto, CA 94304
-
Closed to Enrollment
Colorado
National Jewish Health, Denver, CO 80206
-
Closed to Enrollment
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
-
Closed to Enrollment
Massachusetts
Boston Children's Hospital, Boston, MA 02115
-
Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
-
Closed to Enrollment
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, NC 27514
-
Closed to Enrollment
Oregon
Oregon Health & Science University, Portland, OR 97239
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Closed to Enrollment
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, PA 15224
-
Closed to Enrollment
Texas
University of Texas Southwestern, Dallas, TX 75390
-
Closed to Enrollment
Washington
University of Washington Medical Center, Seattle, WA 98195
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years to 60 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
50 to 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Potential participants will either have mutations that are not eligible to receive CFTR modulator therapy or are no longer taking CFTR modulator therapy due to intolerance or other reasons.
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