A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
• Sign an informed consent form (ICF) voluntarily.
• At the time of signing the ICF, you must be between 18 and 70 years old (inclusive), male or female.
• A diagnosis of SLE according to the 1997 revised criteria of the American College of Rheumatology (ACR).
• The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening.
⁃ Standard treatment regimen refers to the steady use of any of the following (alone or in combination) : corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressants or immunomodulators including azathioprine, Mycophenolate Mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
⁃ Oral corticosteroids must meet the following requirements:
• Prednisone (or equivalent) ≥7.5 mg/ day, and ≤30 mg/ day.
• There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants.
• At least 8 weeks of treatment prior to screening, and the dose must be kept stable for \> 2 weeks.
⁃ 5\. Screening is positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies.
⁃ 6\. SELENA-SLEDAI score ≥8 during the screening period. Score ≥6 for SELENA-SLEDAI clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present.