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New treatment option for Lupus Erythematosus, Systemic
Official title A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
ClinicalTrials.gov ID: NCT06581198
What this study is testing
What is rapcabtagene autoleucel?
rapcabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus erythematosus, systemic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American...
- Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \>= 1:80 (on...
- 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...
- Inadequate response at screening to at least two therapies Key
You likely can't join if
- Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Bernardino, California, United States
- San Francisco, California, United States
- San Pablo, California, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Clayton, Victoria, Australia
- Graz, Austria
- Vienna, Austria
- Salvador, Estado de Bahia, Brazil
- Barretos, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
+ 68 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Bernardino, California, United States; San Francisco, California, United States; San Pablo, California, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 82 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.