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.
Auf einen Blick
Worum geht es in dieser Studie?
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.
Wichtige Erkenntnisse
- 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.
Wer könnte berechtigt sein?
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.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- 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.
Was beinhaltet die Teilnahme?
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.
Potenzielle Risiken und Vorteile
Locations (107)
- University Of AlabamaVerifizierte PostleitzahlBirmingham, Vereinigte Staaten
- Loma Linda UniversityVerifizierte PostleitzahlSan Bernardino, Vereinigte Staaten
- UCSFVerifizierte PostleitzahlSan Francisco, Vereinigte Staaten
- Sutter Health NetworkVerifizierte PostleitzahlSan Pablo, United States
- Ann and Robert H Lurie Childs HospVerifizierte PostleitzahlChicago, Vereinigte Staaten
- Northwestern UniversitätVerifizierte PostleitzahlChicago, Vereinigte Staaten
- University Of IowaVerifizierte PostleitzahlIowa City, Vereinigte Staaten
- University of KentuckyVerifizierte PostleitzahlLexington, Vereinigte Staaten
- Tufts Medizinisches ZentrumVerifizierte PostleitzahlBoston, Vereinigte Staaten
- Boston Medical CenterVerifizierte PostleitzahlBoston, Vereinigte Staaten
- WA Uni School Of MedVerifizierte PostleitzahlSt. Louis, Vereinigte Staaten
- Duke Clinical Research InstituteVerifizierte PostleitzahlDurham, Vereinigte Staaten
Häufige Fragen
Was ist CAR-T-Zelltherapie?
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.
Will I have to stay in hospital?
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.
Was passiert, wenn ich meine Meinung ändere?
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.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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