A Study of Equecabtagene Autoleucel Injection (Eque-cel) in the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE).
• Age≥18 years old, male or female;
• Subjects with relapsed/refractory SLE:
‣ Subjects must be diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria; the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥8, with a British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥1 organ at screening, or a BILAG-2004 activity score of B in ≥2 organs.
⁃ Subjects with lupus nephritis (LN) must be diagnosed with active, biopsy-confirmed lupus nephritis of type III, IV, or V, or type III/IV combined with type V according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria; the SLEDAI-2000(SLEDAI-2K) score ≥8;
⁃ Regular treatment with glucocorticoids and at least two immunosuppressants,immunomodulators, antimalarials, or biologics for at least 3 months, but withpoorly-controlled symptoms or intolerance to treatment.
• Disease-related pathogenic antibody positive: anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
• After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year post Eque-cel infusion (excluding contraception safety periods).
• Subjects must provide written informed consent before the study begin.