Rapcabtagene Autoleucel for Lupus Nephritis or SLE
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
Recruiting
Phase 2Interventional Study
Lupus Erythematosus, SystemicLupus Nephritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
179 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with active systemic lupus erythematosus (SLE) or lupus nephritis that has not responded to previous treatments. Participants will receive a single treatment with rapcabtagene autoleucel after a prior lymphodepletion process.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with lupus erythematosus.
I have at least one specific autoantibody in my blood.
I have active lupus nephritis without chronic signs.
I have a SLEDAI-2K score of 6 or higher.
I have not responded well to at least two treatments.
You may not be able to join if
I have an acute lupus flare that needs immediate treatment.
I have poor organ function.
I have a history of serious heart issues.
I am HIV positive.
I have a current infection with hepatitis B or C.
I have had a serious blood clot in the last month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
* Participant must be positive for at least one of t…
Key Inclusion Criteria:
* Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening.
* Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
* Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus
* SLEDAI-2K Criteria at screening: SLEDAI-2K score \>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to "fever", "lupus headache", "alopecia", and "organic brain syndrome".
* Inadequate response at screening to at least two therapies
Key Exclusion Criteria:
* Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy
* Inadequate organ function during screening and prior to randomization
* History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization
* 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.
Other protocol-defined inclusion/exclusion criteria may apply.
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