At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- rapcabtagene autoleucel (biological)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- rapcabtagene autoleucel — biological: single infusion of rapcabtagene autoleucel
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at a treatment called rapcabtagene autoleucel for people with active systemic lupus erythematosus (SLE) — often just called lupus — or lupus affecting the kidneys (lupus nephritis). The treatment is a type of therapy called CD19 CAR-T, which uses the body's own immune cells. The study is run by Novartis Pharmaceuticals.
Who can take part
- Men and women aged 18 to 75 with SLE, meeting standard 2019 criteria for the condition at screening.
- A positive blood test for at least one lupus-related antibody (ANA, anti-dsDNA, or anti-Sm), checked by a central laboratory.
- Active lupus nephritis without signs of long-term kidney damage, or active systemic lupus.
- An active lupus disease score (SLEDAI-2K) of 6 points or more at screening, not counting certain symptoms like fever or hair loss.
- Lupus that has not responded well to at least two previous treatments.
Who may not be able to
- A severe lupus flare at screening that needs urgent treatment, other than pulse steroids, or that makes stopping current medicines unsafe.
- Organs (such as the liver or kidneys) not working well enough during screening.
- Heart problems or abnormal heart traces (ECG) that could make taking part unsafe.
- HIV infection.
- Hepatitis B or hepatitis C infection.
- A blood clot (grade 2 or higher) in the 4 weeks before screening.
- Other criteria in the study plan may also apply.
What taking part involves
- • Receiving rapcabtagene autoleucel, a CD19 CAR-T therapy made from the body's own immune cells.
- • Stopping some existing lupus medicines before treatment (called a washout).
- • Blood tests and heart checks during screening.
Time commitment: Not stated — ask the trial team about how many visits are needed and how long the study lasts.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 179
- Started
- 2024-09-04
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for lupus erythematosus, systemic
- • Phase2 - 179 participants
- • The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN)
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with lupus erythematosus, systemic
Where?
- • Sheffield - Novartis Investigative Site
- • London - Novartis Investigative Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus
- ✓Inadequate response at screening to at least two therapies
Who cannot take part
- ✗Inhealthy organ during screening and prior to randomization
- ✗History or current diagnosis of ECG or heart abnormalities indicating significant risk of safety for participants...
- ✗Human immunodeficiency virus (HIV) positivity at screening.
- ✗Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.
- ✗Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.
See the full criteria
Where Is This Study? (2 UK sites)
Novartis Investigative Site
Sheffield S10 2JF, United Kingdom
Novartis Investigative Site
London W12 0HS, United Kingdom