IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial, called IMPT-514, is looking at a new treatment for people with certain autoimmune diseases, specifically Systemic Lupus Erythematosus (SLE), ANCA-associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM). The researchers want to understand how safe the treatment is, how it works in the body, and how effective it may be. Participants will receive a single dose of a special therapy called IMPT-514 through an intravenous (IV) infusion, which means it will be given directly into the bloodstream.

To be eligible for the trial, participants need to be 18 years or older, weigh more than 35 kg, and have been on a stable medication regimen for their autoimmune disease for at least four weeks before joining the study. Importantly, the study is open to anyone, regardless of gender, who meets these criteria. Participants can expect to receive close monitoring during the trial to ensure their safety and to gather information about how well the treatment works. This trial is currently recruiting participants, and it aims to provide valuable insights into a potential new option for managing these challenging conditions.

Gender

ALL

Eligibility criteria

• General Inclusion Criteria:
• • 1. Willing and able to provide written informed consent.
• • 2. Age 18 years of age or older and ≤75 years.
• • 3. Weight \> 35 kg at enrollment.
• • 4. On stable background therapy (such as mycophenolate, cyclophosphamide, etc.) for autoimmune disease (SLE, AAV, IIM) with stable dose of immunosuppressants for at least 4 weeks prior to screening.
• For SLE participants:
• • 1. Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or 2012 Systemic Lupus Collaborating Clinics (SLICC) criteria, including positive ANA \>1:80 or positive anti-dsDNA.
• For AAV participants:
• • 1. Meets the diagnostic criteria for ANCA vasculitis in 2022 ACR/EULAR, including microscopic polyangiitis (MPA), granulomatous polyangiitis (GPA), and eosinophilic granulomatous polyangiitis (EGPA).
• For IIM (Dermatomyositis, Anti-Synthetase Syndrome, and Immune-Mediated Necrotizing Myopathy) participants:
• • 1. Diagnosis of probable or definite IIM with subgroup classification of dermatomyositis, or immune-mediated necrotizing myopathy (IMNM) subgroup of polymyositis.
• Exclusion Criteria:
• • 1. Any clinically significant underlying illness, other than systemic autoimmune disease (SLE, AAV, IIM), which would pose a safety risk or concern, as determined by the Investigator.
• • 2. Rapidly progressive glomerulonephritis.
• • 3. For SLE participants: Active central nervous system (CNS) lupus.
• • 4. History of, or current significant neurologic disease.
• • 5. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (such as kidney, lung, heart transplant) or plans for such transplantation in future.
• • 6. History of prior CAR T treatment, autologous or allogeneic.
• • 7. Drug induced SLE, drug induced vasculitis or drug induced myopathy or myositis.
• • 8. Any primary immunodeficiency.
• • 9. History of, or current significant cardiovascular dysfunction.