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What is a clinical trial?

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 take part 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 volunteers take part in to help us find out important information about a medicine, device, or procedure, such as:

Does it work?
What are the risks or side effects?
Is it better than existing treatment options?

Clinical trials can offer patients access to investigational therapies with care and monitoring for the duration of the clinical trial. More information about clinical trials is available in this clinical trials booklet.

What is the investigational CAR-T therapy that is being studied?

Investigational CAR‑T therapy is a personalized therapy made from each patient’s own immune cells. It modifies a person’s immune system to target harmful B cells that contribute to autoimmune diseases.

These clinical trials are looking at how effective investigational CAR‑T therapy is at helping people with autoimmune diseases who have been relying on the long-term use of other medications. Investigational CAR-T therapy is being tested and is not yet FDA-approved, so there is no guarantee there will be a personal benefit.

What are the trial objectives?

The AUTOGRAPH trials are Phase 2 trials to learn about Novartis’s investigational CAR-T therapy.

We are investigating its safety and effectiveness to see if it can help improve the lives of people with severe or refractory autoimmune diseases. Throughout the trial your autoimmune disease will be monitored to see if it has improved after treatment. Your overall health will also be monitored for any signs of side effects.

There are four separate trials, each looking at Novartis’s investigational CAR-T therapy in autoimmune diseases which are known to involve B cells. These are lupus (SLE / LN), myositis (IIM), diffuse cutaneous systemic sclerosis (dcSSc), and vasculitis (AAV).

AUTOGRAPH clinical trials:

What to expect if you participate in an AUTOGRAPH trial

Overall, the Novartis investigational CAR-T trials (known as the AUTOGRAPH clinical trials) will last for up to 6 years, depending on which trial you enroll in. The trials have several stages. If you are receiving investigational CAR-T therapy the stages will be:

Screening: Assessments are carried out to make sure that you and the trial are a good fit
Pre-treatment: We’ll collect T cells from your blood (see What to expect with investigational CAR-T therapy [link]) so that we can make your investigational treatment. You’ll also be given medicines to prepare your body for the investigational CAR-T therapy
Treatment: You’ll be given your investigational treatment in a one-time infusion into the vein. After that you’ll need to stay in hospital for at least 2 weeks so the trial team can closely monitor you. After that you will need to stay within 2 hours’ travel of the hospital for a further 2 weeks
Follow-up: After you’ve been discharged from hospital, you’ll need to come to the trial clinic for additional visits so that we can continue to monitor your health
Long-term follow-up trial: Once you have completed the trial, you may be asked to join a long-term follow-up trial.

Who can take part in the trials?

We are looking for people to take part in clinical trials for Novartis’s investigational CAR-T cell therapy. To be included, we need people who, among other criteria:

Are between 18 and up to 75 years old
Have severe autoimmune disease, either lupus (SLE / LN), myositis (IIM), diffuse cutaneous systemic sclerosis (dcSSc), or vasculitis (AAV), and have not responded well to previous treatments
Have adequate organ function (how well your organs are working)
Do not have other medical conditions that would prevent their ability to tolerate lymphodepletion (lowering specific white blood cells temporarily) and investigational CAR-T therapy

For more information about the trial and other eligibility criteria, see the links below. If you aren’t sure if this applies to you, please contact your doctor or the trial team for more information. The team will look at your full medical history to help you find out if the trial is right for you. By requesting more information, you won’t be committing to join a trial.

What support is available during the trial?

Clinical sites may be able to support you financially and with travel so that we can ensure you have the easiest experience possible. They may 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 committee approval. Speak to the trial team for more detailed information on support that may be available to you.

GLOSSARY

Antibodies Proteins made by your immune system to fight infections.
AUTOGRAPH The name given to the clinical trials for Novartis’s investigational CAR-T therapy.
Autoimmune diseases A group of diseases in which a person’s immune system attacks their own body.
B cell A type of white blood cell that helps protect your body by making antibodies. In some diseases, B cells can become overactive or damaged, which is why treatments like CAR-T cell therapy may target them.
CAR (Chimeric Antigen Receptor) A special protein added to your T cells in the lab so they can recognize and attach to certain cells in your body. This change helps your T cells to find and destroy the diseased cells once they are infused back into you.
CAR-T cell Your own immune cells (T cells) that have been modified in a lab to recognize and target harmful B cells.
Cytokines Natural chemical messengers made by immune cells that help them communicate.
Effectiveness/efficacy How well a therapy, treatment, or medicine works.
Infusion When medicine or CAR-T cells are given slowly into a vein through an intravenous (IV) or central line.
Leukapheresis A procedure where some of your white blood cells (T cells) are collected from your blood using a special machine. The rest of your blood is returned to your body. These cells are later genetically modified in the lab to make CAR-T cells.
Lymphodepletion A short course of medicine given before your investigational CAR-T therapy infusion to make space in your immune system and help the new investigational CAR-T cells work better.
Molecule A biological building block that has a specific function in the body.
Monitoring Regular checks, examinations, and visits done by the trial team to follow your health and safety during and after treatment.
Pathogen An organism, e.g., bacteria, virus, or fungus, that can cause an infection.
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.
Refractory Describes a disease which is not responding well to treatment.
Safety Whether a therapy, treatment, or medicine has side effects/adverse events, what the side effects are, and how serious they are.
Severe Describes a disease that is very bad or intense, and which has a major impact on daily life.
Side effect (adverse event) An unwanted or unexpected reaction to a medicine or treatment, such as fever, nausea, or tiredness. Some are mild and temporary, while others may need medical care.
Trial team The group of doctors, nurses, coordinators, pharmacists, and other professionals who manage the trial and patient care.
T cell A type of white blood cell that helps your body fight infections and diseases. In investigational CAR-T therapy, your own T cells are collected and changed in a lab so they can better recognize and attack harmful cells.
Tissue A group of cells that combine together to form a bigger structure e.g., an organ, muscle, or tendon.

Novartis Clinical Trials

For more information about Novartis clinical trials for patients and caregivers, please visit our Novartis website

References

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