A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

This study is looking for adults aged 18 or older who have certain severe autoimmune diseases. Specifically, you might be eligible if you have Systemic Lupus Erythematosus (Lupus), Idiopathic Inflammatory Myopathy (muscle inflammation), Systemic Sclerosis (scleroderma), or Rheumatoid Arthritis. Your condition must be active and severe, meaning that it is significantly affecting your body.

Crucially, you would only be considered if your disease has not improved enough with several standard treatments prescribed by your doctor. This means you would have already tried different medications, like steroids or other immune-suppressing drugs, for a certain period, and they haven't adequately controlled your illness. The specific requirements for each disease are quite detailed, focusing on how your illness is diagnosed, its current activity, and your past treatments.

For example, if you have Lupus, you would need to meet particular diagnostic guidelines and have active disease affecting a major organ (not just skin or joints). For muscle inflammation, you'd need severe muscle or skin issues, confirmed by specific tests or symptoms, and also show that your current treatments aren't working. The study is open to both men and women.

If you join this study, you'll first have a screening period to make sure you meet all the requirements. This will involve several hospital visits, checks, and tests. Once confirmed, you'll undergo a process where some of your immune cells (T cells) are collected, usually from your blood, and sent away to be specially prepared as CC-97540. Before you receive the CC-97540, you'll likely receive some chemotherapy medicines (Fludarabine and Cyclophosphamide) to help make space for the new cells.

Then, the prepared CC-97540 cells will be given back to you through a drip, similar to a blood transfusion. You might also receive another medication called Tocilizumab. After receiving the cell therapy, you will have regular follow-up visits to the hospital. At these visits, doctors will monitor your health very closely, perform various blood tests, scans, and physical examinations to check for any side effects and see how the treatment is affecting your disease. The total duration of your involvement in the study, including screening, treatment, and follow-up, will be explained in detail by the study team, but it will involve a series of ongoing assessments over a significant period.