A Phase 1/2a, Open Label, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX103 in Subjects With Moderate to Severe Treatment-Refractory Crohn's Disease
Tr1X, Inc.
Summary
This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.
Description
Please see our study website at https://www.cdclinicaltrial.com
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and females ≥ 18 and ≤ 65 years of age at time of consent. 2. Weight of ≥ 40 kg. 3. Medical history and biological evidence of active bowel inflammation documented by: * Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and; * Endoscopic evidence of CD diagnosis at least 3 months prior to and/or at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader) 4. Active disease defined as moderate to severe active CD at Screening defined by all of the following: * Evidence of mucosal inflamma…
Interventions
- BiologicalTRX103
TRX103 is an investigational research product that may treat and provide long term relief to individuals suffering from Crohn's Disease.
- DrugCyclophosphamide
Low dose cyclophosphamide conditioning.
Locations (13)
- Mayo Clinic ArizonaScottsdale, Arizona
- University of California, DavisSacramento, California
- University of California, San FranciscoSan Francisco, California
- University of FloridaGainesville, Florida
- NorthwesternChicago, Illinois
- University of ChicagoChicago, Illinois