Phase 12a Study to Test Safety and Early Effectiveness of TRX103 for Adults with Moderate to Severe Crohns Disease Not Responding to Treatment

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an investigational product called TRX103 for adults with moderate to severe Crohns Disease that has not responded to other treatments. This study focuses on understanding how different doses of TRX103 work and how safe they are when given to individuals with this condition. The trial is sponsored by Tr1X, Inc. and includes participants aged 18 to 65 years with active bowel inflammation confirmed by medical tests. Participants will receive TRX103 in one of several dosing groups, some of which include a conditioning treatment with low dose cyclophosphamide. The study has multiple cohorts receiving different dose levels, including dose levels 1, 2, and 3, with or without conditioning. The treatment is given as an infusion, and the study is open-label, meaning both participants and researchers know which treatment is given. The goal is to find the best dose that balances safety and preliminary effectiveness. Throughout the study, participants will have regular assessments including endoscopic examinations to measure bowel inflammation, blood and stool tests to evaluate biomarkers of disease activity, and patient-reported outcomes to track symptoms and quality of life. Safety and tolerability of TRX103 will be closely monitored from baseline up to one year after infusion. The total participation involves multiple visits over this period to collect data on the treatments impact and side effects.

Treatment of Moderate to Severe Refractory Crohn's Disease