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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing Phase 1 — do you know why it was stopped, and does that tell us anything important about the safety or effectiveness of IMPT-514 for my condition?
2Since this was an early Phase 1 trial focused on measuring dose-limiting toxicities and serious adverse events, what does that mean about how much we actually know about whether IMPT-514 is safe or works for SLE, ANCA-associated vasculitis, or myositis?
3Given that the trial is no longer enrolling and has been terminated, are there any other active trials studying similar approaches for my specific diagnosis that might be worth looking into instead?
4Would continuing or starting a standard approved treatment be a more reliable path right now, given that this early-phase trial was stopped and we have limited safety and benefit data from it?
5Is there any published or preliminary information from this trial about what kinds of adverse events or dose-limiting toxicities were observed, and should those findings factor into how we think about my treatment options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. History of prior CAR T treatment, autologous or allogeneic.
. Drug induced SLE, drug induced vasculitis or drug induced myopathy or myositis.