U.S. Clinical Trial
The Regulate-RA clinical trial is for adults living with rheumatoid arthritis in the United States. The trial will test a new investigational cell therapy product, SBT777101, to determine if it can safely and effectively treat symptoms of RA in patients who have a history of inadequate response to therapies designed to treat RA. SBT777101-01 is not approved by the FDA for the treatment of RA as the safety and efficacy have not yet been established.
Participants may be able to join the trial if they meet the following requirements*:
18 to 70 years old
Confirmed diagnosis of moderate to severe adult-onset rheumatoid arthritis (RA)
Have previously tried at least 3 approved biologic or targeted synthetic therapies (e.g.: Humira, Xeljanz, Rituxan, Enbrel, etc.) for RA
* Additional trial requirements will apply and be discussed with you by your trial team.
If you qualify and decide to participate, you can expect to complete the following:
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Participation in a clinical trial is voluntary. You can ask any questions you have and may leave the trial at any time, for any reason.
Visit the trial clinic map to find a clinic near you or on clinicaltrials.gov.
Trial Clinic LocationsSBT777101 is a cell therapy, meaning it is made from the patient’s own immune cells called regulatory T cells. Blood cells are collected from the patient with RA and then modified to have a special protein on their surface that targets a specific marker related to inflammation. After these modified cells are expanded and stimulated, they are given back to the patient. Strict procedures are in place to ensure the product's identity and safety at every step, from cell collection to administration.
Learn more about the Regulate-RA clinical trial and cell therapy by watching the video below.
Investigational means the trial cell therapy is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research trials like SBT777101-01 (Regulate-RA). Learn more about investigational therapies by clicking here.
Rheumatoid Arthritis (RA) is an autoimmune disease. In patients with RA, the immune system targets and damages the tissue lining their joints, leading to pain, swelling, stiffness and inflammation.
Here are some common questions and answers about trial participation.
Clinical research trials help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the trial, including trial goals, how long the trial will last, benefits and risks, and the tests and procedures you will receive.
Trial participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a trial.
Participation in clinical research trials is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research trial, contact a trial clinic near you.
Use the filters, map, and listing to find the trial clinic closest to you. Contact the trial clinic to learn more.