Overview
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active, refractory lupus nephritis and systemic lupus erythematosus.
IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year.
Participants will continue in long-term follow-up for 15 years from treatment.
Eligibility
Inclusion Criteria:
- Willing and able to provide written informed consent
- Age 18 years of age or older
- Weight > 45 kg at enrollment
- Adequate blood pressure control
- 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
- LN participants: Active, biopsy-proven, proliferative lupus nephritis Class III or IV by 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
Other protocol-defined criteria apply.
Exclusion criteria:
- 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
- Rapidly progressive glomerulonephritis
- Active central nervous system (CNS) lupus
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation
Other protocol-defined criteria apply.
