NCT06462144TerminatedEarly phase 1
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
An Exploartory Trial of IMPT-514, An Autologous Anti-CD19/20 CAR T Therapy in Participants With Active, Refractory Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Terminated
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 4 Jun 2024
- Start date
- 13 Jun 2024
- Primary completion date
- 21 Oct 2025
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Lupus (SLE), ANCA-associated vasculitis
- NCT number
- NCT06462144
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior CAR T treatment, autologous or allogeneic.
- Drug induced SLE, drug induced vasculitis or drug induced myopathy or myositis.
Other illness
- 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.
- 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, or current significant cardiovascular dysfunction.
Other
- Rapidly progressive glomerulonephritis.
- For SLE participants: Active central nervous system (CNS) lupus.
- Any primary immunodeficiency.
Criteria the registry did not label
- General 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.
- For SLE participants:
- 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:
- 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:
- Diagnosis of probable or definite IIM with subgroup classification of dermatomyositis, or immune-mediated necrotizing myopathy (IMNM) subgroup of polymyositis.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | China | Unknown status |
| Zhongshan Hospital,Fudan University | Shanghai | China | Unknown status |
| The affiliated hospital of xuzhou medical university | Xuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.