A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)

Korábbi kezelés

• History of prior B cell directed cell therapy, including CAR T treatment, autologous or allogeneic, as well as prior bispecific or T cell engager therapy
• Drug-induced SLE
  • Other protocol-defined criteria apply.

Más betegség

• Any clinically significant underlying illness, other than SLE and LN, which would pose a safety risk or concern, as determined by the Investigator
• Any other systemic autoimmune condition
• History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation

Egyéb

• Rapidly progressive glomerulonephritis
• Active central nervous system (CNS) lupus

• Willing and able to provide written informed consent
• Age 18 years of age or older
• Weight > 45 kg at enrollment
• Adequate blood pressure control
• On stable background therapy for autoimmune disease (LN, SLE) with stable dose of autoimmune disease medications for at least 4 weeks prior to screening
• Diagnosis of SLE by 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or 2012 Systemic Lupus Collaborating Clinics (SLICC) criteria, including positive ANA or positive anti-dsDNA
• Positive anti-nuclear antibody (ANA), anti-dsDNA (double stranded DNA) or anti-Smith antibody at screening
• SLE participants: SLEDAI-2K ≥ 6 points, with at least 4 points on clinical, non-laboratory items
• SLE participants: British Isles Lupus Assessment Group (BILAG) 2004 level B in 2 or more organ systems, or BILAG level A in 1 or more organ system
• Physician Global assessment ≥ 1 on 0 to 3 visual analogue scale (VAS)
• LN participants: Active, biopsy-proven, proliferative LN Class III or IV by 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
  • Other protocol-defined criteria apply.