Participate in Research at CU Anschutz

This study involves chimeric antigen receptor (CAR) T cell therapy, which is a relatively new therapeutic approach that uses a patient's own immune cells to treat their disease. In autoimmune diseases such as rheumatoid arthritis (RA), certain parts of the immune system are overactive, leading to inflammation. A subtype of immune cells, called regulatory T cells (Tregs), normally help to reduce inflammation. As part of this study, we will take a patient’s Tregs and genetically modify them into CAR Tregs. These genetically modified CAR Tregs made from their Tregs are called SBT777101. The purpose of this study is to learn about the safety and tolerability of SBT777101.

What happens at the study visits? Screening: You will receive screening health assessments to confirm if you qualify to join the trial. You will answer questions about your medical history, symptoms, and current medications. Joint Biopsy: You will have a biopsy of your joints once during screen and once after the SBT777101 cell therapy infusion. Synovial tissue is the connective tissue that lines your joints. Synovial fluid works with the synovial tissue to keep your joints lubricated. Collecting some of your synovial tissue or fluid will help confirm if you are eligible for the SBT777101 cell therapy. Apheresis Procedure: This procedure will allow the trial doctor to collect the cells from your blood to make the SBT777101 cell therapy. During apheresis, your blood will be drawn into the apheresis machine from one arm (or catheter) and separated into components. White cells will be removed, and the plasma red cells will be returned to each arm. The procedure lasts about 2-3 hours. SBT777101 Cell Therapy Infusion: After more trial health assessments, you will receive an IV infusion of SBT777101 through a needle in your arm. You will need to remain at the clinic overnight so the trial doctor can monitor your health. Follow Up Visits: You will return to the trial clinic for safety follow up visits. You will need to attend about 15 visits over the course of about 11 months. Follow up visits will include more trial health assessments, including physical exams, blood and urine samples, and another joint biopsy.