ClinicaliQ Trial Snapshot
- A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH – SLE/LN) — Recruiting • Phase II • Rheumatology • NCT06581198.
- What is being tested: Rapcabtagene autoleucel, a one-time CAR-T cell therapy administered after lymphodepletion, in patients with active, treatment-refractory systemic lupus erythematosus or lupus nephritis.
- Patient eligibility overview: The trial targets patients with active disease that has proven resistant to standard therapies, representing a population with limited treatment options and significant unmet clinical need.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.