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.
Principal investigator
Eligibility criteria
Exclusion Criteria: 1. Any clinically significant underlying illness, other than SLE and LN, which would pose a safety risk or concern, as determined by the Investigator 2. Any other systemic autoimmune condition 3. Rapidly progressive glomerulonephritis 4. Active central nervous system (CNS) lupus 5. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation 6. 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 7. Drug-induced SLE Other protocol-defined criteria apply.
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