Study on the Effects of Rapcabtagene Autoleucel in Patients with Systemic Lupus Erythematosus and Active, Refractory Lupus Nephritis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called rapcabtagene autoleucel in people with a condition known as systemic lupus erythematosus (SLE), which is a disease where the immune system attacks the body’s own tissues. Specifically, the study targets those with a severe form of SLE that affects the kidneys, called lupus nephritis. The purpose of the study is to compare the effectiveness and safety of rapcabtagene autoleucel against the standard treatments currently used for this condition.

Participants in the study will receive either rapcabtagene autoleucel or one of the standard treatments, which may include medications like cyclophosphamide, voclosporin, belimumab, rituximab, mycophenolate mofetil, tacrolimus, or fludarabine phosphate. Rapcabtagene autoleucel is a type of cell therapy that involves modifying a person’s own immune cells to better fight the disease. The study will last for about a year, during which participants will be monitored to see how well the treatment works and to check for any side effects.

The study is designed to help researchers understand if rapcabtagene autoleucel can provide better outcomes for patients with lupus nephritis compared to the current standard treatments. Participants will be assessed for improvements in their condition and any changes in their health over the course of the study. This research aims to find more effective ways to manage and treat lupus nephritis, potentially offering new hope for those affected by this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

Blood tests and other diagnostic procedures may be performed to ensure the presence of systemic lupus erythematosus (SLE) with active lupus nephritis (LN).

2 treatment allocation

Participants are randomly assigned to receive either the investigational treatment, rapcabtagene autoleucel, or the standard of care (SOC).

The investigational treatment involves a single infusion of CAR-positive viable T cells following a preparatory phase called lymphodepletion.

3 lymphodepletion

Before receiving the investigational treatment, participants undergo lymphodepletion. This process involves the administration of medications to reduce the number of certain immune cells.

Medications used may include cyclophosphamide and fludarabine phosphate, administered through intravenous infusion.

4 administration of rapcabtagene autoleucel

Following lymphodepletion, participants receive a single infusion of rapcabtagene autoleucel.

This infusion is administered intravenously and is designed to target and modify specific immune cells.

5 monitoring and follow-up

Participants are monitored regularly to assess the treatment’s effects and any potential side effects.

Regular check-ups include blood tests, urine tests, and other assessments to evaluate kidney function and overall health.

6 evaluation of clinical response

The primary goal is to evaluate the clinical response at Week 52, focusing on remission and kidney function improvement.

Secondary evaluations include fatigue levels, disease activity scores, and safety assessments.

7 completion of study

The study concludes with a final assessment to determine the long-term effects of the treatment.

Participants may be asked to continue follow-up visits to monitor their health beyond the study period.

Who Can Join the Study?

  • You must sign a form to show you agree to take part in the study.
  • You should be a man or woman with systemic lupus erythematosus (SLE), which is a condition where the immune system attacks the body, and be between 18 and 65 years old.
  • You need to have certain antibodies in your blood. These are proteins that the immune system makes. The specific antibodies are called antinuclear antibodies (ANA), anti-dsDNA, or anti-Sm.
  • You must have active lupus nephritis, which is a kidney problem caused by lupus, but it should not be a long-term issue. This needs to be confirmed by a kidney biopsy, which is a test where a small piece of kidney tissue is examined.
  • Your urine protein creatinine ratio (UPCR), a test that measures protein in your urine, should be between 1.0 and less than 7.0 grams per gram in a 24-hour urine collection.
  • Your SLEDAI-2K score, which measures lupus activity, should be 6 points or more. This score does not include points for fever, lupus headache, hair loss, or brain issues.
  • You should have tried at least two different treatments for lupus nephritis, each for at least 3 months, but they did not work well enough. These treatments include certain medications like cyclophosphamide, mycophenolic acid, belimumab, azathioprine, rituximab, cyclosporin, tacrolimus, or voclosporin.

Who Cannot Join the Study?

  • Patients who have a different condition than systemic lupus erythematosus (SLE) with active, difficult-to-treat lupus nephritis (LN) cannot participate. Systemic lupus erythematosus (SLE) is a disease where the immune system attacks the body, and lupus nephritis (LN) is when this disease affects the kidneys.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not meet the gender requirements for the study cannot participate.
  • Patients who are considered part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Klinikum Nuernberg Nürnberg Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Azienda Sanitaria Locale Di Pescara Pescara Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
University Of Debrecen Debrecen Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centre Hospitalier Universitaire De Rennes Rennes France
University Hospital Olomouc Olomouc Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Hopital Beaujon Clichy France
Universitaetsklinikum Leipzig AöR Leipzig Germany
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Frankfurt Germany
Fundeni Clinical Institute Bucharest Romania
Ugrpanwldwtrmhcwkjlcx Evxpc Ahl Essen Germany
Lphhy Utqhakgpjqbp Mhhwnar Czletby (bgapm Leiden The Netherlands
Umfaewbeylcq Mosifgb Cftxvko Gobfgbojm Groningen The Netherlands
Haklkucq Uodjdzujjeibs Mhzqehy Dm Vtmarfkdaz Santander Spain
Wuzownaybzh Wtttppmywaheotluyssp Cqwukzw Oqiyyqypm I Tyfhxtorgwloe Ix Muljojrrfnr W Lgqyh Lodz Poland
Cvaklmuc Hvxjngrtxuwh Ujnrzpslnfhzh Dv Vkud Vigo Spain
Uorkrdmtnc Heyxcctx Cowlygz Cologne Germany
Aseboswvrf Peujbalv Hgipxxnh Ds Mwuywogzz Marseille France
Swabvhmbh Rwvsmmy Uhggjlnjta Mqbwbxx Ckoxoc Nijmegen The Netherlands
Aokija Ubcmuwjout Htpgwjgl Aarhus Denmark
Czrk Dl Nyfda Vandoeuvre Les Nancy France
Ahxklnn Obmyfjxrqyc Njudetmfy Sl Agizfzi E Buwlli E C Asocxh Acfbzulfsjt Alexandria Italy
Hfkdcwvn Vypc dtcprrus Barcelona Spain
Ifpbautz Pmtmjafxnsaroqc Cqztts Cmwcyi Marseille France
Hyyluesy Ulvftqrgvhnltl Saolbmtxri &xaksfz Hadjvgw dw Htmbribpozw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
02.12.2024
Czechia Czechia
Recruiting
02.12.2024
Denmark Denmark
Recruiting
02.12.2024
France France
Recruiting
02.12.2024
Germany Germany
Recruiting
02.12.2024
Hungary Hungary
Recruiting
02.12.2024
Italy Italy
Recruiting
02.12.2024
Norway Norway
Recruiting
02.12.2024
Poland Poland
Not yet recruiting
02.12.2024
Romania Romania
Recruiting
02.12.2024
Spain Spain
Recruiting
02.12.2024
Sweden Sweden
Recruiting
02.12.2024
The Netherlands The Netherlands
Recruiting
02.12.2024

Trial locations

Rapcabtagene Autoleucel is a type of gene therapy used in this clinical trial. It involves modifying a patient’s own T cells to help them better recognize and attack certain cells in the body. This therapy is being tested to see if it can improve the condition of patients with systemic lupus erythematosus (SLE) who have active, difficult-to-treat lupus nephritis (LN).

Standard of Care (SOC) refers to the usual treatment given to patients with systemic lupus erythematosus and lupus nephritis. This can include a variety of medications and therapies that are commonly used to manage symptoms and control the disease. The trial compares the new therapy, rapcabtagene autoleucel, to these standard treatments to see which is more effective.

Systemic Lupus Erythematosus (SLE) – This is an autoimmune disease where the body’s immune system mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs. Symptoms vary widely among individuals and can include fatigue, joint pain, rash, and fever. The disease often progresses with periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, SLE can lead to complications in various organs, particularly the kidneys, known as lupus nephritis. The severity and progression of the disease can differ greatly from person to person.

Trial ID:
2023-510150-17-00
Protocol code:
CYTB323J12201
NCT ID:
NCT06581198
Trial Phase:
Therapeutic exploratory (Phase II)

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