IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory… (NCT06462144) | Clinical Trial Compass
TerminatedEarly Phase 1
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
Stopped: The collaborating party has adjusted its R\&D strategy and terminated the study.
China3 participantsStarted 2024-06-13
Plain-language summary
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent.
✓. Age 18 years of age or older and ≤75 years.
✓. Weight \> 35 kg at enrollment.
✓. 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.
Exclusion criteria
✕. 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.
✕. Rapidly progressive glomerulonephritis.
✕. For SLE participants: Active central nervous system (CNS) lupus.
✕. History of, or current significant neurologic disease.
✕. 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.
What they're measuring
1
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAE) and treatment-emergent adverse events (TEAEs).
Timeframe: 28 days from cell infusion
Trial details
NCT IDNCT06462144
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School