A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of IMPT-514 in Participants With Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

Description

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.

Trial Eligibility

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age 18 years of age or older 3. Weight \> 45 kg at enrollment 4. Adequate blood pressure control 5. 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 6. 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: 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 Other protocol-defined criteria apply.

Study Info

Interventions

Locations Recruiting

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