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Clinical Trial Finder
Genetic Therapy Enrolling
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)
This study will evaluate the safety and tolerability of RTC2100, 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 RTC2100. 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.
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:
40% or greater
For a more comprehensive list of eligibility criteria and details on this study, 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:
7 months -
Number of Study Visits:
17
Additional Information
-
Phase: ?more info
Phase One -
Study Sponsor: ?more info
ReCode Therapeutics -
Study Drugs:
Study Sites
-
Enrolling Soon
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233
Contact
Heather Hathorne
Phone: +1 (205) 638-9568
Email: hyhathorne@uabmc.edu
-
Enrolling Soon
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Elizabeth Ryan
Phone: +1 (520) 850-8688
Email: elizabethryan@arizona.edu
-
Enrolling Soon
California
University of California San Diego, La Jolla, CA 92037
Contact
Jenna Mielke
Phone: +1 (619) 471-0822
Email: jmielke@health.ucsd.edu
-
Enrolling
California
Stanford University Medical Center, Palo Alto, CA 94304
Contact
Jacquelyn Spano
Phone: +1 (650) 721-1132
Email: jmzirbes@stanford.edu
-
Enrolling
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
Contact
Ashleigh Streby
Phone: +1 (404) 727-0305
Email: ashleigh.streby@emory.edu
-
Enrolling
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.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 Soon
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, NC 27514
Contact
Julie Goudy
Phone: +1 (984) 974-2364
Email: julie_goudy@med.unc.edu
-
Enrolling Soon
Oregon
Oregon Health & Science University, Portland, OR 97239
Contact
Jenna Bucher
Phone: +1 (503) 494-7807
Email: bucherj@ohsu.edu
-
Enrolling Soon
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
-
Enrolling Soon
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-6233
Email: Ashley.Keller@UTSouthwestern.edu
-
Enrolling
Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Lauren Bartlett
Phone: +1 (503) 583-2869
Email: lrejman@uw.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:
40% or greater
For a more comprehensive list of eligibility criteria and details on this study, 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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