A Phase I Study of BAFF CAR-T Cells (LMY-920) for Treatment of Systemic Lupus Erythematosus
This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores.
• Age 18-69 years
• Confirmed Systemic Lupus Erythematosus (SLE) as per Systemic Lupus International Collaborating Clinics (SLICC) 2012 Criteria with one or more of the following:
• a. Active disease despite use of standard therapy (i) and one or more additional therapies (ii).
• i. Corticosteroids (CS), Hydroxychloroquine ii. Mycophenolate mofetil (MMF), Methotrexate (MTX), Azathioprine (AZA), Tacrolimus (TAC), Cyclophosphamide (CYC), Rituximab, and/or belimumab b. Active disease due to intolerance of standard therapy (i) and one or more additional therapies (ii).
• c. Steroid-Dependent Disease
• Subjects must meet organ function criteria:
‣ Creatinine clearance more than or equal to 30 ml/min calculated by the Cockcroft - Gault formula
⁃ Subjects must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 40% on the most recent echocardiogram.
⁃ Adequate pulmonary function with pulse oximetry ≥92% on room air
⁃ Total Bilirubin ≤ 1.5x the institutional upper limit of normal (except in patients with Gilbert's syndrome)
⁃ ALT (SGPT) and AST (SGOT) \< 3x the institutional upper limit of normal