If you join this study, you will help researchers learn more about SC291, a new kind of treatment called CAR T cell therapy. Before you get the treatment, the study team will check to make sure you can take part and will give you medicine through an IV to prepare your body. You will then get one dose of SC291 in the hospital. You may need to stay in the hospital for several days afterwards so that doctors can watch for any side effects. After leaving the hospital, you will keep having checkups for two years, and doctors will continue to monitor your health for up to 15 years or longer to watch for any signs of cancer. During the study, doctors will check your weight, vital signs, mental health, and heart. You will also have a small amount of blood and urine taken at each visit. You’ll also need to stay close to the clinic and avoid driving for 28 days after your treatment. You will be in the main part of the study for about two years and have around 33 visits to a clinic or at home. You will be in the main part of the study for about two years and have around 33 visits to a clinic or at home. You will get up to $4,150 if you complete all visits while receiving treatment. You can also get $50 for home visits, long-term follow-up visits, or any extra unscheduled visits. You may also be repaid for things like travel, hotel stays, meals, and help with child or pet care.

Who can Participate

You may be able to join this study if you are an adult with a serious autoimmune disease that has not gotten better with treatment. One condition is lupus nephritis, which is a type of lupus that affects the kidneys. To qualify, you need to have had a kidney biopsy showing Class III or IV lupus nephritis (Class V may also be included). You also need to have tried at least two treatments. The first should be mycophenolate mofetil (MMF) or cyclophosphamide. The second should be one of the following: rituximab, belimumab, voclosporin, or obinutuzumab. You may also qualify if you have extrarenal lupus (ERL), which is lupus that affects other parts of the body besides the kidneys. Your symptoms must be serious, and you must have already tried at least two treatments that didn’t help. These treatments might include MMF, azathioprine, cyclophosphamide, methotrexate, rituximab, belimumab, IVIg, abatacept, or anifrolumab. Steroids like prednisone do not count toward this list. Another condition in this study is ANCA-associated vasculitis (AAV). This disease makes the immune system attack the blood vessels. To take part, you must have either granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). You must have had a serious flare-up after your disease was under control. You may have been treated before with rituximab, obinutuzumab, cyclophosphamide, or steroids (glucocorticoids). Your condition must be life-threatening or affect important organs, and you must test positive for PR3 or MPO antibodies.

Study ID

More information available at ClinicalTrials.gov: NCT05878184