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

2 1 1 1

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
Ospedale San Raffaele S.r.l. Milan Italy
Karolinska University Hospital Solna Sweden
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital General Universitario Gregorio Maranon Madrid Spain
Fundeni Clinical Institute Bucharest Romania
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Semmelweis University Budapest Hungary
Radboud universitair medisch centrum Nijmegen The Netherlands
Rcmhypjteiwmxi Urgmb Prague Czechia
Kkhshhsi Ncjzndsrj Nürnberg Germany
Ulitliksbd Oa Dsnsyobw Debrecen Hungary
Ifmjczhr Pabtkhknawzfyrw Ccngyz Cdlgjz Marseille France
Hsryqiac Vipj dphtlqmq Barcelona Spain
Fihsoikxbs Ivfnpjzzr frj Tgckuhpybivqv Mxlnlhqt ahc Pclbmwyqzrcg Iqkm Frankfurt Germany
Uktjqtypqu Hshskxdp Cosypfn Cologne Germany
Ftmqzlvhkf Ikezt Co Gvsqvi Oozrwqgj Mpsiscws Pkfcqbjxpuu Milan Italy
Fuymjclzck Ieoay Pumaapjdhqu Shn Mxyysc Pavia Italy
Ayiyrgtxos Puqgpgoi Hinorvkt Df Metwvlbhf Marseille France
Uoodpnhpxmqi Mvuwohl Cjngssf Uqlxuap Utrecht The Netherlands
Iivqy Okusnyzq Pdpmumsjumz Srp Mkdqrlm Genoa Italy
Cazueg Hipjokvmjwz Umsyfjasdtikp Dv Mmsizbjnrik Montpellier France
Ujzjsqnlubtaocnjm Pctalcylryg Ddyep Mccvgw Ancona Italy
Urylyajyxwyo Dh Snzsyaqc Df Cboodhquko Santiago De Compostela Spain
Cbho Dg Ndzlx Vandoeuvre Les Nancy France
Cukhau Hhtxqunqbqy Udabxgsebxbbf Dm Rdgybk Rennes France
Utszgiyqbusasycpvcchc Egicj Auy Essen Germany
Ugjkdqaypcdv Mffhmbv Cvmnify Gfubdlxqu Groningen The Netherlands
Ukxofbsapqluultloxgvl Slcwdubehlmasahtgq Aiy Kiel Germany
Hmjobtxg Uelelithwascv 1s Dk Oljylmr Madrid Spain
Htfshmia Uvfskkwelwblo Mvziwrj Dm Vjicxmowzr Santander Spain
Wwhcanmexfv Wyjvoyxefpzrxqlmlnog Cpihuzx Olxxauuui I Tsjxrqpdltnrs Ip Mmgwwjhvkgs W Lolie Lodz Poland
Cmrtbszk Haerowxzjkyb Ubfjjeqghrbhy Dl Vfph Vigo Spain
Umqdwkrsyxyffqzfkiujw Lbfrnex Aim Leipzig Germany
Hbswswty Uruwljgomofgle Supqfapuuy &wvkvjg Hahnvwj du Hbfxqddyhug STRASBOURG, Alsace France
Ajlgdwg Orrlxoxldvs Uymfmrqmuxqio Pgljwo Pisa Italy
Apnsqh Urmcgtqprn Hfiypdbf Aarhus Denmark
Aqmpwoj Oqnavnzvjvu Neuexphsh Sd Ahmsmav E Bgxaks E C Akrnuw Aauoiqaozqz Alexandria Italy
Lsweg Uxihbuunzxax Mfyvusk Cscnnnp (mzyig Leiden The Netherlands
Rppuxn Bhtfl Khzffqxumua Gyeh Stuttgart Germany
Aopturg Saosloabu Lyschn Dx Pyxpffh Pescara Italy
Ccrtap Hckoojgssfx Usaypavffmevp Dq Bldpzgns Bordeaux France
Ajrolxxujb Parvypug Hzjpnxqi Dy Paiba Paris France
Cfamri Hsotwrpmjkc Uxvfovxoibmig Dm Txiohraz Toulouse France
Mtwoycf Uzdaagtewb On Ghei Graz Austria
Ufabkeegookydleiamqyf Uwi Arg Ulm Germany
Vnafyvjrj Fqssjslm Nxzqvnoke V Pxrio Prague Czechia

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)

Other Trials to Consider

  • A Phase 3 Study of Enpatoran to Treat Active Cutaneous Lupus in Patients With or Without Systemic Disease

    Recruiting

    3 1
    Belgium Bulgaria Czechia France Germany Greece +4
  • Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus

    Recruiting

    3 1
    Investigated Drugs:
    Bulgaria Czechia Denmark Finland France Germany +9