IMPACT-MS is a clinical trial for Progressive Multiple Sclerosis
A new investigational cell therapy to address the root causes of progressive multiple sclerosis and help restore balance in the body.
About the IMPACT-MS Clinical Trial
We’re testing the safety and efficacy of a new investigational therapy for people with progressive multiple sclerosis.
An approach to cellular therapies for immune diseases that scales
We combine the latest advances in genetic engineering with decades of research on T cells to create effective cell therapies to treat inflammation and autoimmune disease that can be made at a large scale.
What to expect in the trial
Your guide to what happens in the IMPACT-MS 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 Form (ICF). The ICF clearly explains what the trial involves, what tests and visits to expect and confirms that you’re willing and able to participate.
As you review the ICF you 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 this trial. After you sign the ICF you will begin your screening period, during which you will complete a series of medical tests and assessments in order to confirm that this trial is a good fit for you.
TRX319 infusion
TRX319 is given as an intravenous (IV) infusion at the trial site. The infusion lasts ~30 minutes and is administered by trained medical staff. Depending on your specific circumstances, your doctor may recommend that you receive up to three total infusions of TRX319 over an approximately two month period.
You will be closely monitored during the infusion, and a member of the trial team will be available to answer any questions and help ensure you are comfortable.
Immediately following your TRX319 infusion, your doctor will closely monitor you to make sure you are doing well. This monitoring may include up to a two night stay at the clinical site so the care team can observe how your body is responding to the treatment and quickly respond to any side effects, if needed.
These steps are taken to support your safety and ensure you receive the care and attention you ended following treatment.
After your TRX319 infusion, you will need to return to the trial site for follow-up visits with your study doctor for up to 48 weeks. These ~15 follow-up visits help the care team monitor how you are feeling and how the therapy is performing. You may need additional visits if you receive multiple doses of TRX319.
You will also be invited to participate 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 you for any potential side effects and 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.
Washington University
UCI Health - Irvine
University of Kansas Medical Center
UC San Diego Health
Cleveland Clinic - Mellen Center for Multiple Sclerosis
Mayo Clinic (Rochester, MN)
University of Pennsylvania - Perelman Center for Advanced Medicine
What to know about the trial
Answers to common questions about the clinical trial
What is Progressive MS?
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 TRX319?
TRX319 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 (Tregs). Tregs are the peacekeepers of your immune system, ensuring that it doesn’t attack itself by mistake. Type 1 regulatory (Tr1) T cells are a distinct subset of Tregs.
In MS, B cells mistakenly trigger the immune system to attack the protective covering of the nerve cells, particularly in your central nervous system. TRX319 is an allogeneic CAR Tr1 Treg cell therapy which has been designed to act like both a Tr1 cell, which enables it to help calm inflammation, and a CAR T cell, which enables it to target and eliminate the B cells the fuel MS, helping to restore balance to your immune system.
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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