RecruitingPHASE2INTERVENTIONAL

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

This research study, called AUTOGRAPH, is looking into a new treatment named rapcabtagene autoleucel for people aged 18 to 75 who have quite severe lupus (Systemic Lupus Erythematosus) or lupus that affects their kidneys (Lupus Nephritis). These are people whose lupus hasn't responded well to at least two other medicines. The main aim is to check if this new one-time cell therapy is both effective at controlling the disease and safe to use. Patients will receive a special type of cell therapy after a brief preparation to clear some existing immune cells. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

179

Start

04 Sep 2024

Estimated completion

06 Feb 2032

Lupus Erythematosus, Systemic Lupus Nephritis

What is this study about?

This study is particularly for people living with Systemic Lupus Erythematosus (SLE), often just called lupus, or a specific type of lupus that impacts the kidneys, known as Lupus Nephritis. We're looking for individuals whose lupus symptoms are still active and severe, even after trying at least two different treatments. The new treatment being investigated is called rapcabtagene autoleucel. This is a type of cell therapy, which means it uses specially modified cells from your own body to fight the disease.

The main goal of the AUTOGRAPH study is to carefully assess how well rapcabtagene autoleucel works in these situations and to ensure it's safe for patients. Before receiving the main treatment, participants will undergo a short preparation to reduce some of their existing immune cells. The rapcabtagene autoleucel is then given as a single treatment. By participating, you would be helping doctors and researchers understand if this new approach could offer a new option for people with challenging lupus.

Finding new and more effective treatments for severe lupus and lupus nephritis is really important because current treatments don't work for everyone, and having active disease can significantly impact quality of life. This research is part of a larger effort to improve care for these conditions, and your involvement could contribute valuable information to the medical community.

Key takeaways

This study is testing a new cell therapy for severe lupus or lupus nephritis.
It's for people whose current treatments haven't worked well.
The main goals are to check how well the treatment works and if it's safe.
Participants will receive the treatment once and be closely monitored.
Eligibility depends on specific lupus diagnosis and overall health.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you generally need to be an adult between 18 and 75 years old diagnosed with Systemic Lupus Erythematosus (SLE) according to specific medical guidelines. Your lupus must be active and severe enough to have caused you problems, even after trying at least two different treatments, or you might have active lupus nephritis (lupus affecting the kidneys). Also, blood tests must show that you have certain types of autoantibodies, which are markers often seen in lupus.

There are also some reasons why you might not be able to join. For example, if you have a very severe lupus flare right now that needs immediate treatment, or if you have certain heart problems, active infections like HIV or hepatitis, or recent serious blood clots. The medical team will check your organ functions to make sure you're healthy enough to take part.

Quick self-check

Are you between 18 and 75 years old?
Have you been diagnosed with Systemic Lupus Erythematosus (SLE) or Lupus Nephritis?
Is your lupus currently active despite trying at least two other treatments?
Are your blood tests positive for certain lupus markers (like ANA or anti-dsDNA)?
Do you have good general organ health without severe recent infections or heart problems?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to participate in this study, you would first go through a screening process to confirm you meet all the requirements. This involves various tests and assessments. If you qualify, you would then receive the study treatment, rapcabtagene autoleucel, as a single infusion after a preparatory treatment to clear some of your immune cells. Afterwards, you would have regular visits to the hospital or clinic so the doctors can monitor your health, check for side effects, and see how the treatment is affecting your lupus. The total duration of your involvement, including follow-up, will be explained in detail by the study team. You will be fully informed about all the steps involved before making any decision.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might have access to a new treatment for your lupus that isn't yet widely available, and it could potentially help control your severe symptoms if other treatments haven't worked well. However, it's also important to be aware of potential risks. As with any strong medication or cell therapy, there could be side effects, which the medical team will explain in detail. These could include reactions to the treatment or effects on your immune system. You will receive very close monitoring throughout the study. Remember, deciding to participate is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (101)

University Of Alabama
Birmingham, United States· Recruiting
Loma Linda University
San Bernardino, United States· Recruiting
UCSF
San Francisco, United States· Recruiting
UCSF
San Francisco, United States· Recruiting
Sutter Health Network
San Pablo, United States· Recruiting
Ann and Robert H Lurie Childs Hosp
Chicago, United States· Recruiting
Northwestern University
Chicago, United States· Recruiting
University Of Iowa
Iowa City, United States· Recruiting
University of Kentucky
Lexington, United States· Recruiting
Tufts Medical Center
Boston, United States· Recruiting
Boston Medical Center
Boston, United States· Recruiting
WA Uni School Of Med
St Louis, United States· Recruiting

+89 more sites — see the official record for the full list.

Common questions

What is 'rapcabtagene autoleucel'?

It's a new type of cell therapy that uses your own specially modified immune cells to treat severe lupus or lupus nephritis.

What does 'refractory' mean in this study?

It means your lupus hasn't responded well to at least two other standard treatments.

Will I have to stay in the hospital for this treatment?

The study team will explain the exact process, but cell therapies often involve a hospital stay for the treatment and initial monitoring.

What age range is this study for?

This study is for adults aged between 18 and 75 years old.

Can I stop participating if I want to?

Yes, you have the right to leave the study at any time without it affecting your other medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.