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

Launched by LYELL IMMUNOPHARMA, INC. · Nov 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMPT-514 for patients with active lupus nephritis (LN) and systemic lupus erythematosus (SLE), which are autoimmune diseases that can cause inflammation and damage to various organs. The trial aims to evaluate how safe and effective this treatment is. Participants will receive a single infusion of specially modified T cells (a type of immune cell) after undergoing a preparatory treatment to reduce their immune system temporarily. The study will follow participants for about a year after treatment, with long-term follow-ups lasting up to 15 years.

To be eligible for the trial, participants must be at least 18 years old, weigh more than 45 kg, and have a confirmed diagnosis of SLE or LN. They should also be on stable medication for their condition for at least four weeks before joining the study. It’s important that potential participants do not have other significant health issues that could complicate their treatment. If you or a loved one is interested, this trial is currently recruiting participants from various locations.

Gender

ALL

Eligibility criteria

• 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. On stable background therapy for autoimmune disease (LN, SLE) with stable dose of autoimmune disease medications for at least 4 weeks prior to screening
• • 6. 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
• • 7. Positive anti-nuclear antibody (ANA), anti-dsDNA (double stranded DNA) or anti-Smith antibody at screening
• • 8. SLE participants: SLEDAI-2K ≥ 6 points, with at least 4 points on clinical, non-laboratory items
• • 9. 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
• • 10. Physician Global assessment ≥ 1 on 0 to 3 visual analogue scale (VAS)
• • 11. 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.
• 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.