This study is being done to learn whether TRX103, an investigational regulatory T‑cell therapy, can safely reduce gut inflammation, help the bowel heal, and improve symptoms in people with Crohn’s disease who have not responded well to other advanced treatments. Researchers also want to better understand how this therapy affects the immune system over time.

You may qualify for this study if you:

• Are an adult with moderate to severe Crohn’s disease
• Have little to no relief from prior treatment (tried 2 or more unsuccessful treatments of Crohn’s disease)
• Diagnosed with Crohn’s disease for at least 1 year
• Not diagnosed with ulcerative colitis
• Able to travel to the Cleveland Clinic for study visits (Cleveland, OH)
• Not currently pregnant

• Pre-screening and screening: You’ll first answer questions about your health and medical history to see if you may qualify. If you move forward, you’ll have screening visits that may include physical exams, blood tests, and other assessments to confirm eligibility.

• Study enrollment: If you qualify and choose to join, you’ll be assigned to either a single‑dose or multi‑dose TRX103 group.

• Study treatment: You’ll receive TRX103 by IV infusion at the study site according to your assigned dosing schedule. Study staff will monitor you closely during and after each infusion.

• Follow-up visits: Over about 12 months, you’ll attend regular study visits (approximately 20–23 total, depending on your group) for exams, lab tests, and questionnaires about your symptoms and overall health.

• Daily diary: You’ll be asked to complete a brief daily diary about your symptoms, well‑being, and medications.

• Additional safety checks if needed: If your study doctor has any concerns, you may be asked to come in for extra visits or tests to ensure your safety.

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Participants may receive up to $2300 dollars for participating in this study. This amount includes $100 dollars for each completed study visit, with approximately 23 visits in total, depending on the dose schedule you are assigned to. You may also be reimbursed for necessary transportation expenses that occur as a result of attending study visits. All study-related care is provided at no cost.

There is no cost for you to participate in our research study.