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Study Title: A Study of CC-97540 in Participants with Severe, Refractory Systemic Lupus Erythematosus (srSLE)

Sponsor Name: Bristol Myers Squibb

Purpose of Study: The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory systemic lupus erythematosus (srSLE). Patients with srSLE have a type of lupus that does not go into remission despite receiving appropriate therapies.

What Does this Study Involve?

About 43 individuals will be enrolled in this study. Participation will last a little over two years and consist of the following periods:

• Pre-study treatment period: You will attend one or more screening visits before the study treatment period begins. At screening, certain tests and procedures may be done to make sure you are eligible to participate in the study. In preparation for the investigational therapy, you will complete a procedure called leukapheresis. You will be connected to a machine that circulates your blood to collect the T cells that will then be genetically modified at a BMS laboratory before they are returned to your bloodstream. This procedure may take a few hours and will prepare your body for the investigational therapy.
• Study treatment period (approximately five weeks): Following a single infusion of the investigational therapy, you will remain in the hospital to be monitored for two weeks*. During these first two weeks, you will have six study visits at which you will undergo procedures such as vital sign measurements, physical exams, blood and urine sample collections, and answering questionnaires. Following your release from the hospital, you will be asked to stay within one hour’s travel of the clinical facility for an additional 14 days, meaning that this period will last for at least 28 days following infusion. If you live over an hour away from the treating facility/study treatment center, BMS may be able to help cover expenses for your stay once you are released from the hospital.     
• Before receiving the investigational therapy, you will undergo a treatment known as lymphodepleting (LD) chemotherapy. This is administered to reduce certain white blood cells in the body so that they do not attack the CAR T cells that are introduced during the investigational therapy infusion. You will be contacted by an experienced CAR T health care provider via phone call every day that you are not in the hospital or visiting the study site, until the end of the first four weeks.
• Study follow-up period: You will attend up to 11 follow-up visits to check on your health for two years after receiving the investigational therapy. These visits will include procedures such as physical exams, blood and urine sample collections, and questionnaires.
• Long-term follow-up period: After the study has been completed, you may enter a long-term follow-up from year two to year 15. This will include occasional check-ins to monitor your health after receiving the investigational therapy.

You May Qualify for This Study If You:

• Are at least 18 years of age.
• Have a diagnosis of SLE.
• Have severe, refractory SLE that has not responded well to standard treatments.
• Do NOT have a diagnosis of drug-induced SLE rather than idiopathic SLE.
• Have NOT received prior CAR T cell therapy, genetically modified T cell therapy, or a stem cell transplant.          

There are additional eligibility criteria, which a study doctor can explain to you.

Study Type:

• Interventional
• Phase 1 multicenter
• Currently a US study, will be expanding internationally in 2024

Learn More

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.