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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Systemic Lupus Erythematosus, Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT06153095

Run by

Lyell Immunopharma, Inc.

People needed

0

Starts

2024-02-15

Expected to finish

2025-01-09

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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.

Where it is running

• University of California, Los Angeles (UCLA) Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Iowa — Iowa City, Iowa, United States
• Westmead Hospital — Westmead, Australia

Full record on ClinicalTrials.gov

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