A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis

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Description

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.

Details
Age

Adult

Eligibility

To be eligible for this study a participant must meet all the following criteria: - Age 18-70 years - Diagnosis of moderate to severe rheumatoid arthritis (RA) that is not well managed by current medications - Have tried and failed to respond to medications for the treatment of RA - Have at least one swollen knee, wrist, or ankle that can be used for joint biopsy- Have tried and failed to respond to at least 3 biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for the treatment of RA, which includes but is not limited to Humira, Enbrel, Simponi, Remicade, Actemra, Kevzara, Orencia, Rituxan, Xeljanz, and Rinvoq - BMI < 35

Locations

University of Colorado Hospital

Principal Investigator
Photograph of Larry Moreland

Larry Moreland

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