Do you have systemic lupus that isn’t well managed by your current treatment? The invisible weight of lupus can be exhausting.
Consider joining the CA061-1001 study for people living with severe refractory systemic lupus.
Short Study
Summary
Medical Condition:
Systemic Lupus Erythematosus (SLE)
Participation duration:
14 weeks, with a 24 month follow up period
Phase:
I
About Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus (SLE) is an autoimmune disease, that causes your immune system to mistakenly damage healthy cells in your body. SLE can cause symptoms in almost any organ system, including the kidneys, lungs, and skin, but the most common symptoms include fatigue, fever, joint pain or swelling, and skin rashes (often seen in a butterfly shape across the cheeks and nose). Your symptoms can be classified as mild, moderate or severe, and for this study your symptoms must be severe to participate.
What is the CA061-1001 study?
Part of what causes lupus is that certain cells in the immune system (called B cells and plasmablasts) don’t function correctly. These abnormal cells contribute to the symptoms and damage caused by lupus, and are not well controlled by current treatment options. This investigational research study is investigating a potential new treatment, referred to as CC-97540, for systemic lupus. The investigational treatment, is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy that modifies cells in the immune system (called T cells) so that they can recognize and destroy the abnormal B cells and plasmablasts better.
The CA61-1001 study is a Phase 1 study that is currently recruiting and has patients enrolled. The investigational treatment is called investigational as it is currently not approved by regulatory authorities for use in lupus for the purposes of this study.
If you are found to be eligible, you will be contacted by the research center who will be able to provide you with more information and answer any additional questions that you have.
Who can participate in the CA061-1001 study?
You may be eligible to participate in the CA061-1001 study if you:
Are aged 18 or older
Have a confirmed diagnosis of system lupus erythematosus
Have currently active, severe disease
Have tried at least 3 types of medications for lupus
What happens if I participate?
The first step is to see if you might qualify for the study. The online pre-screener (insert link here) will help us understand basic information about your possible eligibility. If you pass the online screener, you will be contact for more detailed pre-screening by our medical panel. During this discussion, you will be able to ask questions about clinical research and this study. If you pass the secondary pre-screening, you will then be contacted directly by the center nearest to you (or the center of your choice).
Whether or not you decide to join the CA061-1001 study is completely your decision and all participation is voluntary. You can withdraw at any time and for any reason with no negative impact on your overall care.
STEP 1: Pre-treatment period
This is the time when the study doctor and staff determine if you are eligible, and you decide if you want to participate. This step can take up to 6 to 8 weeks, during which the study team will perform tests to find out if you can participate in the study.
If you meet all entry requirements during screening and choose to participate, you will then undergo leukapheresis. Leukapheresis is a procedure where blood is collected and run through a machine to collect immune cells, then the blood is returned to your body.
The immune cells that are collected from leukapheresis will then be used to create the modified T cells. This process is performed in a laboratory and takes approximately 4 weeks.
STEP 2: Treatment Period
If your modified T cells are produced successfully, you are well enough and continue to meet eligibility for treatment, and you decide to move forward, you will then enter the treatment period. This period lasts approximately 5 weeks.
Approximately 5 days before investigational treatment, patients must undergo a treatment that is given intravenously for 3 consecutive days. After this treatment, the investigational treatment can begin. This includes a 14 day inpatient stay at the hospital for monitoring. After the in-patient portion of the treatment period is finished, you will need to attend outpatient visits at the clinic at least 2 times a week for the next 2 weeks.
STEP 3: Post-treatment period
After completing the treatment period, you will start the post-treatment period. During the first 24 months after treatment, you will have follow-up visits to monitor your health.
You will also be asked if you would like to participate in a separate long-term follow-up study for approximately 15 years.
How do I Participate?
Complete
the online questions to see if you pre-qualify
Submit
Answer
Confirm
Speak
with the study site about the next steps to participate
Frequently Asked Questions
Where can I find more information about this study?
You can learn more about this study by visiting clinicaltrial.gov.
What is a clinical research study?
Clinical studies explore whether a new drug, treatment, or device is safe and effective for humans.
Clinical studies are scientific studies in which new drugs and treatments are tested to find out if they are safe and effective for people to take and use. They are one of the most important steps in bringing new potential treatments to patients.
Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new potential treatments to people with medical conditions. To bring new treatments to the public, they need be assessed in clinical studies, to determine if they work and are safe.
Clinical studies rely on the participation of volunteers. It can take several years for a new potential treatment to reach the public. Often, this timeline is due to how long it takes to complete the clinical study, which can be due to shortage of participants.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical or biotechnology companies, academic medical centers, voluntary groups, or health care providers. The CA061-1001 study is funded by a biopharmaceutical company.
Every clinical study center is led by a principal investigator, who is a medical doctor. Clinical studies also have a research team that may include doctors, nurses, and other health care professionals.
What are the phases of clinical research studies?
Clinical studies are conducted in different phases.
Phase 1: After researchers have investigated the potential new drug or treatment in laboratory tests or in animals to see if it has an effect and ensure that it is safe to test in humans, the Phase 1 study is carried out to test the potential new drug or treatment in a small group of people for the first time. This is done to evaluate its safety, determine a safe dosage range, and identify potential side effects. The potential new drug or treatment is referred to as a study drug or study treatment since it is under investigation and not yet approved for use in normal clinical practice.
Phase 2: The study drug or study treatment is given to a larger group of people (compared to Phase 1) to see if it is effective and to further evaluate its safety.
Phase 3: The study drug or study treatment is given to large groups of people to confirm its efficacy, monitor side effects, compare it to commonly used treatments or placebo, and collect information that will allow the study drug or study treatment to be used safely.