RecruitingPhase 1Phase 2NCT06721962

Treatment of Moderate to Severe Refractory Crohn's Disease

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


Sponsor

Tr1X, Inc.

Enrollment

39 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called TRX103 for moderate to severe Crohn's disease that has not responded to multiple prior therapies. Crohn's disease is a chronic inflammatory bowel condition, and this study is for patients who have already tried and failed at least two advanced treatments. **You may be eligible if...** - You are between 18 and 65 years old and weigh at least 40 kg - You have had Crohn's disease for at least 1 year, confirmed by endoscopy - Your disease is currently active and moderate to severe, based on both imaging and symptom scores - You have already tried and failed (or could not tolerate) at least 2 advanced therapies such as TNF inhibitors, anti-integrins, IL-12/23 inhibitors, or JAK inhibitors - If you are on steroids, your dose is low and stable **You may NOT be eligible if...** - You have serious infections, active tuberculosis, or a history of certain serious illnesses - You have significant liver, kidney, or heart problems - You are pregnant or unwilling to use contraception - You are currently on certain medications that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Arizona

Scottsdale, Arizona, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Florida

Gainesville, Florida, United States

Northwestern

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Louisville

Louisville, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University in St. Louis

St Louis, Missouri, United States

Mount Sinai Health Systems

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06721962


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