A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Systemic lupus erythematosus (SLE) and lupus nephritis (kidney inflammation caused by lupus) are autoimmune conditions where the immune system mistakenly attacks healthy tissues. For some people, standard treatments do not bring symptoms under control. This Phase 2 clinical trial is investigating a specialised treatment known as CAR-T cell therapy (rapcabtagene autoleucel). Doctors collect some of the patient's own white blood cells, modify them in a laboratory so they can target the cells driving the inflammation, and return them through a single drip. Before receiving the cells, participants have a short course of treatment to prepare their bodies. The main goal of the trial is to find out whether this one-time infusion is safe and effective at reducing disease activity and providing lasting relief for people whose lupus has not responded to at least two previous medicines.
Överblick
Vad handlar denna studie om?
Lupus is a chronic condition where the body's defence system becomes confused and attacks healthy parts of the body, such as the skin, joints, and internal organs. When lupus affects the kidneys, it is called lupus nephritis, which can cause swelling, high blood pressure, and long-term kidney strain. While many people manage their symptoms with standard medicines like steroids or immunosuppressants, others find that these treatments do not work well enough or stop working over time.
This clinical trial is studying a new approach called rapcabtagene autoleucel. It is a type of CAR-T cell therapy, which uses the power of your own immune system. In this treatment, immune cells called T-cells are taken from your blood and gently altered in a specialised laboratory. This teaches them to find and remove the specific rogue cells that produce the harmful antibodies causing lupus flares.
Once the cells are prepared, you receive a brief, mild preparatory medicine to clear room in the body, followed by a single infusion of your updated cells. Researchers hope that this approach will act like a 'reset button' for the immune system, calming disease activity and giving the body a chance to heal without the need for constant heavy medications.
Viktiga punkter
- Tests a personalised, one-time cell therapy designed to reset an overactive immune system.
- Open to adults aged 18 to 75 with active lupus or lupus kidney disease.
- Aimed at people whose lupus has not improved after trying at least two standard treatments.
- Requires a hospital stay after the infusion for careful safety monitoring.
- Participation is entirely voluntary, and you can withdraw at any time.
Vem kan vara berättigad?
You may be able to join this study if you are between 18 and 75 years old and have been diagnosed with active systemic lupus erythematosus or active lupus nephritis. To take part, your condition must still be causing significant symptoms despite having tried at least two standard lupus treatments in the past. Blood tests must also confirm the presence of particular lupus-related antibodies.
You will not be able to take part if you are having a sudden, life-threatening flare that requires emergency care, or if you have serious ongoing heart, liver, or kidney failure. People with active chronic infections like hepatitis B, hepatitis C, or HIV, or those who have had a serious blood clot in the past four weeks, are also unable to join for safety reasons.
A doctor on the study team will carry out detailed health checks, including blood tests and heart scans, to ensure this treatment is suitable and safe for you before you start.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- I am aged between 18 and 75.
- I have a confirmed diagnosis of active systemic lupus erythematosus (SLE) or lupus nephritis.
- I have tried at least two different lupus treatments that did not work well enough.
- I have not had a serious blood clot in the past four weeks.
- I do not have a serious heart condition or an active infection like hepatitis or HIV.
Vad innebär deltagande?
Taking part in this trial involves several clear stages. First, you will attend screening visits to check your general health, organ function, and blood tests. If you are eligible, doctors will collect some of your white blood cells using a routine process similar to giving blood. These cells are sent to a secure laboratory to be prepared, which takes a few weeks.
Before the cells are returned to you, you will have a few days of medicine to prepare your immune system. You will then receive the modified cells through a single intravenous drip, usually while staying in hospital for observation so doctors can monitor you closely for any reactions. Afterward, you will have regular outpatient check-ups over several months to track your lupus symptoms, check blood and urine samples, and ensure you are recovering well.
Potentiella risker och fördelar
Platser (107)
- University Of AlabamaVerifierat postnummerBirmingham, USA
- Loma Linda UniversityVerifierat postnummerSan Bernardino, USA
- UCSFVerifierat postnummerSan Francisco, USA
- Sutter Health NetworkVerifierat postnummerSan Pablo, United States
- Ann and Robert H Lurie Childs HospVerifierat postnummerChicago, USA
- Northwestern UniversityVerifierat postnummerChicago, USA
- University Of IowaVerifierat postnummerIowa City, USA
- University of KentuckyVerifierat postnummerLexington, USA
- Tufts medicinska centrumVerifierat postnummerBoston, USA
- Boston Medical CenterVerifierat postnummerBoston, USA
- WA Uni School Of MedVerifierat postnummerSt Louis, USA
- Duke Clinical Research InstituteVerifierat postnummerDurham, USA
Vanliga frågor
What is CAR-T cell therapy?
It is an innovative treatment where your own immune cells are collected, trained in a lab to recognise and remove the faulty cells causing your illness, and then given back to you.
Måste jag stanna på sjukhuset?
Yes, you will likely need to stay in hospital for a short period after receiving your cells so the medical team can watch for side effects and keep you safe.
Does taking part cost anything?
No. The trial treatment and all study-related medical tests are provided free of charge, and travel expenses are often reimbursed.
Can I continue taking my regular lupus medications?
Some medications need to be paused or adjusted before the cell therapy so they do not interfere with the treatment. The trial doctors will guide you safely through this.
What happens if I change my mind?
You can leave the study at any point. Your decision will never harm your relationship with your healthcare team or your right to standard treatment.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
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