RESTORE is a clinical trial for Crohn's Disease
A new investigational cell therapy to address the root causes of Crohn’s disease and help restore balance in the body.
About the RESTORE Clinical Trial
We’re testing the safety and efficacy of a new therapy for people with moderate to severe Crohn’s disease.
An approach to cellular therapies for immune diseases that scales
We combine the latest advances in genetic engineering with decades of T cell biology research to develop scalable, effective cellular therapies for inflammation and autoimmunity.
What to expect in the trial
Your guide to what happens in the RESTORE clinical trial
Participants in this clinical trial will always be in the care of a doctor, who will monitor them closely throughout the entirety of the trial. For additional information, please see ClinicalTrials.gov.
Monitoring
Follow-Up Visits
All clinical trials have requirements that individuals need to meet to determine if they are eligible to participate. These requirements are explained in a document called an Informed Consent, which you will be asked to review and sign prior to undergoing medical screening.
During the screening period you will undergo different study eligibility assessments and will be able to speak with one of the doctors running the trial to ensure that you understand and are comfortable with what it means to participate in the trial.
TRX103 infusion
TRX103 is given as a one-time intravenous (IV) infusion at the study site. The infusion lasts approximately 30 minutes and is administered by trained medical staff.
You will be closely monitored during the infusion, and a member of the study team will be available to answer questions and help ensure your comfort.
After your TRX103 infusion, your study doctor will closely monitor you to make sure you are doing well. This monitoring may include an overnight stay in the hospital, so the care team can observe how your body is responding and address any side effects as soon as possible.
These steps are taken to support your safety and ensure you receive the care and attention you need following treatment.
After your TRX103 infusion, you will return to the trial site for follow-up visits with your study doctor for up to 40 weeks. These visits help the care team check in on how you are feeling and closely monitor your health over time.
You will also be invited to take part in a separate long-term follow-up study, as required by the U.S. Food and Drug Administration (FDA). This allows your care team to continue monitoring for any potential side effects and to support your safety after treatment.
Understanding the Eligibility requirements
Are you eligible to take part in the clinical trial?
This list does not include all of the trial participation criteria and details. For additional information, please see ClinicalTrials.gov.
University of Michigan | Gastroenterology Clinic
Washington University Center for Advanced Medicine | Gastrointestinal Center
University of Iowa Medical Center
Digestive Health Center at UW Medical Center – Montlake
UofL Health
UF Health
USF Health Morsani Center for Advanced Healthcare
UChicago Medicine
UC Davis Medical Center
Gastroenterology Clinic (UCSF)
Feinstein IBD Clinical Center
Mayo Clinic - Minnesota
Mayo Clinic - Arizona
Cleveland Clinic
Northwestern Medicine Digestive Health Center
What to know about the trial
Answers to common questions about the clinical trial
What is Moderate to Severe Treatment-Refractory Crohn’s Disease?
Crohn’s disease (CD) is a chronic inflammatory bowel disease.
Moderate to severe CD is generally classified as a score between 220 and 450 on the Crohn’s Disease Activity Index (CDAI) or a Simplified Endoscopic Score for CD (SES-CD) of 6 or higher.
Treatment-refractory CD is CD that continues to be inflamed despite two or more approved treatments, such as TNF-alpha inhibitors (Humira, Remicade, Cimzia), IL-12/23 inhibitors (Stelara, Skyrizi), anti-integrins (Entyvio, Tysabri) and/or JAK inhibitors (Rinvoq).
What is a Clinical Trial?
A clinical trial is a research study that looks to find a better way to prevent, diagnose or treat a disease by testing the safety and effectiveness of a new medical treatment. The US Food and Drug Administration (FDA) has strict rules regarding how a clinical trial is performed and reviews the data produced from it to decide if the investigational treatment can be widely used.
A Phase 1 clinical trial is the first step in testing a new treatment in humans. Phase 1 clinical trials typically seek to determine (i) how much of a treatment is safe to give, (ii) the optimal dose and timing of the treatment and (iii) which side effects (if any) are likely to be caused by the treatment.
In a Phase 2 clinical trial doctors want to understand if a treatment has a clinical benefit in addition to whether it is safe and well tolerated in humans.
What is Cell Therapy?
Cell therapy refers to the transfer of new cells, or cells that have been modified in a laboratory to achieve particular characteristics, into the body to prevent or treat a disease. The two major types of cell therapy are autologous (in which the patient receives cells from their own body) and allogeneic (in which the patient receives cells from a healthy donor). This trial is using an allogeneic cell therapy.
What is TRX103?
TRX103 is the current name of an investigational therapy that contains a modified set of T cells from a healthy donor that mimic regulatory T cells. Regulatory T cells are the peacekeepers of your immune system, ensuring that it doesn’t attack your own body by mistake. TRX103 is an allogeneic cell therapy product which has been developed by Tr1X.
How Can I Learn More?
Getting started
Submit your information for eligibility review
This clinical trial is evaluating a potential new treatment for moderate to severe Crohn’s disease. Submit the form to determine potential eligibility.
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