U.S. Clinical Trial

Looking for a new way to manage your Rheumatoid Arthritis (RA) symptoms?

If so, consider joining the SBT777101-01 U.S. clinical trial researching a cell therapy that may provide a new option for people with RA.

Find a clinic near you!

Looking for a new way to manage your Rheumatoid Arthritis (RA) symptoms?

If so, consider joining the SBT777101-01 trial researching a cell therapy that may provide a new option for people with RA.

Find A Clinic Near You!

What is the SBT777101-01 trial?

The SBT777101-01 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.

Who can join the SBT777101-01 trial?

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.

What will happen during the trial?

If you qualify and decide to participate, you can expect to complete the following:

Review & Sign the Informed Consent Form
The Informed Consent Form (ICF) contains information about the trial including its goals, duration, benefits, risks, tests and procedures.
Screening Period (About 4 Weeks)
Receive trial health assessments such as physical assessments, medical history, and demographic information to confirm if you qualify for the trial. This will include a joint biopsy (a needle is used to collect a sample of synovial fluid and tissue).
Pre- Treatment Period & SBT777101 Cell Therapy Preparation (About 6 weeks, up to 6 months is allowed)
Participants will undergo apheresis where blood is collected and separated to manufacture SBT777101. Additionally, participants will have pre-treatment health assessments to determine if it is safe to receive SBT777101.
Trial Treatment Period & Trial Health Assessments
(About 11 Months)
Participants who qualify will receive a single dose of SBT777101 administered intravenously and will be monitored overnight. After infusion, participants will receive ongoing trial health assessments for about 11 months and will have another joint biopsy.
Long Term Follow Up
Continue to the long-term follow up period for up to 15 years. Trial clinic staff will provide more information.

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.

Interested in the SBT777101-01 trial?

Visit the trial clinic map to find a clinic near you or on clinicaltrials.gov.

Trial Clinic Locations

About the Trial Therapy

What is the trial cell therapy?

SBT777101 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 autoimmune diseases such as RA. After expanding and stimulating these modified cells, 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.

What is an “investigational therapy"?

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. Learn more about investigational therapies by clicking here.

Rheumatoid Arthritis (RA)

What is Rheumatoid Arthritis?

Rheumatoid Arthritis (RA) is an autoimmune disease that mostly affects your joints. Your immune system normally helps protect your body from infection and disease, but when you have an autoimmune disease your immune system cannot tell the difference between your cells and foreign cell that leads to disease. When you have RA, your tissues and joints get attacked by your immune system, leading to pain, swelling, stiffness and inflammation.

Overview of Clinical Trials

Here are some common questions and answers about trial participation.

If you have additional questions about participating in a clinical research trial, contact a trial clinic near you.

Trial Clinic Locations

Use the filters, map, and listing to find the trial clinic closest to you. Contact the trial clinic to learn more.

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