Novartis Phase 2 Study of CAR T-Cell Therapy (Rap-cel)
Study Title:
Novartis Phase 2 Study of CAR T-Cell Therapy (Rap-cel) for People With Hard‑to‑Treat Lupus or Lupus Kidney Disease
Sponsor Name:
Novartis
Purpose of Study:
The Novartis research study is testing a potential new investigational treatment that is a single infusion of rapcabtagene autoleucel (also called rap-cel) for patients with active, refractory lupus nephritis (LN) or active, refractory systemic lupus erythematosus (SLE).
- “active” means that the disease is currently causing inflammation and damage.
- “refractory” means that the disease has not improved, even after trying standard treatments like steroids and immunosuppressive medicines.
Rap-cel is an investigational therapy known as Chimeric Antigen Receptor (CAR) T-cell therapy. CAR T-cell therapy uses some of the participant’s own white blood cells, known as T-cells and modifies them to be able to eliminate another type of white blood cell, called B cells, which are believed to contribute to lupus disease activity.
You may be able to participate in this research study if you:
- Are aged 18–75 years.
- Have a confirmed diagnosis of active SLE or LN that hasn’t improved despite at least two prior treatments.
- Meet specific lab test criteria related to lupus.
There are additional eligibility requirements that your doctor will review with you.
You cannot participate in this research study if you:
- Have an acute, severe lupus related-flare that needs immediate treatment by your physician.
- Have very severe heart, liver, or lung issues.
- Have HIV, acute or chronic infection with hepatitis B or C, or untreated tuberculosis.
There are additional eligibility requirements that your doctor will review with you.
If you are interested in this research study and meet the qualifications, you may have a screening visit with a study doctor. The study doctor, together with a review committee of medical experts will decide if you are able to be part of the study.
What will happen during the research study?
This is a single arm study, which means that all participants will receive the new treatment.
- Qualification: The participants will meet with the study team to review their eligibility based on a physical exam and some medical and laboratory tests.
- Cell collection: Participants who qualify will have some of their white blood cells collected. These cells will be sent to a manufacturing facility where they will be converted into CAR T cells, making them able to eliminate B-cells, which are believed to contribute to the disease activity.
- Pre-treatment: Participants will receive medications that reduce the number of white blood cells (lymphodepleting) in preparation for their treatment.
- Treatment and monitoring: Participants will receive their own modified CAR T-cells and continue under close medical supervision for up to four weeks.
- Follow up: Patients will be followed up for a minimum of five years after the treatment.
Costs incurred during clinical trial participation such as travel, lodging and meals may be reimbursed.
Every patient is different and may have different support needs. Ask your doctor about what kind of support may be available to you.
Study Type:
- Phase 2
- Single-arm
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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.