Current treatment options for lupus can help to manage symptoms,
but some people experience side effects that they are unable to tolerate.
Others may not respond as hoped.
Or they respond well but then find that their medication no longer gives them the same benefits.
For these reasons, there is a significant need for targeted and more effective treatment options for people with lupus.
Investigational CAR-T therapy is being tested and is not yet FDA-approved, so there is no guarantee there will be a personal benefit.
In people with systemic lupus erythematosus (SLE) and lupus with kidney inflammation, also known as lupus nephritis (LN), the immune system mistakenly attacks a range of organs, most commonly the kidneys.2
The modified cells are then returned to your body in a one-time infusion. This trial is testing the safety and effectiveness of investigational CAR-T therapy in people with lupus.1
Keep reading to find out more about the purpose of the trial. We’ll talk about the details of how the trial works, what treatment you may receive, and what taking part involves.
The AUTOGRAPH × AUTOGRAPH The name given to the clinical trials for Novartis’s investigational CAR-T therapy. -SLE/LN clinical trial is designed to evaluate the safety × Safety Whether a therapy, treatment, or medicine has side effects/adverse events, what the side effects are, and how serious they are. and effectiveness × Effectiveness/efficacy How well a therapy, treatment, or medicine works. of an investigational CAR-T cell therapy and better understand how it compares with existing treatments...
The AUTOGRAPH × AUTOGRAPH The name given to the clinical trials for Novartis’s investigational CAR-T therapy. -SLE/LN clinical trial is designed to evaluate the safety × Safety Whether a therapy, treatment, or medicine has side effects/adverse events, what the side effects are, and how serious they are. and effectiveness × Effectiveness/efficacy How well a therapy, treatment, or medicine works. of an investigational CAR-T cell therapy and better understand how it compares with existing treatments.
Researchers are looking to see if people with lupus who have been relying on the long-term use of other medications may be able to experience sustained improvement of their disease and quality of life with a once-only CAR-T infusion × Infusion When medicine or CAR-T cells are given slowly into a vein through an intravenous (IV) or central line. .
Information from this trial may help improve future treatment options for people with lupus.
This is a Phase 2 × Phase 2 (clinical trial phase) The stage of a clinical trial where a treatment is given to a larger group of people (often 50–200) to investigate how well it works and to learn more about its safety. trial, which means we are investigating the safety and effectiveness of investigational CAR-T × CAR-T cell Your own immune cells (T cells) that have been modified in a lab to recognize and target harmful B cells. cell therapy compared with commonly used treatments. Not everyone in the trial will receive investigational CAR-T therapy. Some people will receive existing treatments so we can compare any changes fairly...
This is a Phase 2 × Phase 2 (clinical trial phase) The stage of a clinical trial where a treatment is given to a larger group of people (often 50–200) to investigate how well it works and to learn more about its safety. trial, which means we are investigating the safety and effectiveness of investigational CAR-T × CAR-T cell Your own immune cells (T cells) that have been modified in a lab to recognize and target harmful B cells. cell therapy compared with commonly used treatments. Not everyone in the trial will receive investigational CAR-T therapy. Some people will receive existing treatments so we can compare any changes fairly.
If you choose to take part in the AUTOGRAPH × AUTOGRAPH The name given to the clinical trials for Novartis’s investigational CAR-T therapy. -SLE/LN clinical trial, the medication you may receive depends on whether you have lupus only or lupus nephritis.
The trial doctor will explain which treatment options apply to you, how treatment is decided, and what this means before you decide whether to take part.
Clinical sites may be able to support you financially and with travel so that we can ensure patients have the easiest experience possible. They may also be able to support with travel coordination, compensation for trial visits, and visit-associated expenses...
Clinical sites may be able to support you financially and with travel so that we can ensure patients have the easiest experience possible. They may also be able to support with travel coordination, compensation for trial visits, and visit-associated expenses.
Reimbursement policies vary by site and are subject to ethics approval. Speak to the trial team for more detailed information on support that may be available to you.
Clinical trials (or clinical studies) are more than just research. They are an essential part of developing new medicines and thousands of people around the world participate in them every year...
Clinical trials (or clinical studies) are more than just research. They are an essential part of developing new medicines and thousands of people around the world participate in them every year.
Everyone involved in a clinical trial is helping shape the future of care.
Clinical trials are a type of medical research that human volunteers take part in, and help us find out important information about a medicine, device, test, or procedure, such as:
Clinical trials can offer patients access to investigational therapies with care and monitoring × Monitoring Regular checks, examinations, and visits done by the trial team to follow your health and safety during and after treatment. for the duration of the clinical trial.
More information about clinical trials is available in this clinical trials booklet .
We are looking for people to take part in clinical trials for Novartis’s investigational CAR-T cell therapy.
The eligibility information below is a general guide. Final eligibility will be decided during screening and should always be discussed with your doctor.
For more detailed eligibility information, see clinicaltrials.gov and talk to your healthcare professional.
Assessments are carried out to make sure that you and the trial are a good fit
For 8 weeks after treatment, you will need to come into the hospital at least once a week.
After this initial period, visits become less frequent
Assessments are carried out to make sure that you and the trial are a good fit
Taking part in the
AUTOGRAPH
×
AUTOGRAPH
The name given to the clinical trials for Novartis’s investigational CAR-T therapy.
-SLE/LN clinical trial is a personal choice. Joining the trial is completely voluntary, and you can decide not to take part or to leave the trial at any time.
If you do choose to enroll, the trial will require a time commitment and some planning. This includes attending scheduled trial visits, following specific treatment guidelines, and making temporary adjustments to work or daily activities.
The sections below explain these commitments in more detail, so you can understand what taking part may involve and decide whether this trial could be right for you.
Details of this will need to be discussed with your doctor and the trial team. There are some treatments that cannot be taken whilst on the trial.
You may need to stop taking your current treatment before your T cells are collected. This is called a washout period. The trial team will support you to make sure this is done as safely as possible.
If you are receiving a class of medicine known as glucocorticoids (GCs), such as prednisone or dexamethasone, you may need to reduce your dose.
This may have an impact on your ability to work. It may help to talk to your employer about flexible working or medical leave. The trial team can help if you need support with these conversations.
You will need to avoid driving or operating heavy machinery for 8 weeks after receiving investigational CAR-T therapy.
It is not known whether the trial treatment(s) may harm an unborn or nursing baby. If you are pregnant, trying to become pregnant, or breastfeeding, you cannot be in the trial.
There are requirements for contraception for both female and male participants from the time they join and for at least 2 years after receiving the investigational CAR-T therapy.
Cyclophosphamide (used as one of the pre-treatment medications for lymphodepletion) can affect male and female fertility. Your trial team will discuss your potential options for fertility preservations, including risks and outcomes.
Caring for a person with lupus is a vital role, and important to the success of a person’s treatment.
As part of the clinical trial, the person receiving the investigational CAR-T therapy will need to remain in hospital for 2 weeks after the infusion. They will then need to stay within 2 hours’ travel from the hospital for a further 2 weeks. It’s important that you’re aware of this as they may need your support during this time.
These are the key ways that caregivers can help:
To find out more about the AUTOGRAPH-SLE/LN clinical trial and whether you might be eligible, click the link below.
Before anything else happens, you’ll meet with the trial doctor (also called the principal investigator). They will explain the purpose of the trial and who may be able to take part.
The trial team will share the informed consent form and other helpful materials, including short videos. These explain what taking part involves, the possible risks and benefits, and the time commitment.
Informed consent means you take time to learn about the trial, ask questions, and decide whether you want to take part. If you choose to continue, you’ll sign the consent form to confirm that you’re joining voluntarily.
After giving informed consent, you’ll go through a screening process. This helps the trial team check whether the trial is a good and safe fit for you.
Screening may include a review of your medical history, physical exams, and medical assessments. The goal is to confirm that you meet the trial’s requirements and do not have any conditions that would make participation unsafe.
The trial team will explain each step and answer any questions you may have.
If screening shows that you meet all trial criteria, you may be enrolled in the trial. The trial site will confirm your eligibility and guide you through the next steps.
Being enrolled means you can move forward in the trial, but participation remains voluntary throughout. You can choose to stop taking part at any time.
Yes. This trial is unblinded, which means both you and your trial doctor will know which treatment you are receiving. Some trial staff who assess your disease during the trial will not know which treatment you’re on. This helps keep the trial results as fair and accurate as possible.
In most cases, yes. Visitor policies depend on the hospital, so rules may vary. Because your immune system may be weaker, visitors might need to follow safety measures such as wearing masks or washing their hands carefully. Your trial team can explain the visiting hours and any guidelines you or your visitors will need to follow.
No. If you are not receiving the investigational CAR-T therapy, you will continue with safety and effectiveness follow-up visits while receiving the comparison treatment. There is no planned hospital stay for people in this part of the trial.
For more information about Novartis clinical trials for patients and caregivers, please visit our Novartis website.
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