Experimental CAR t therapy targets lupus and related diseases – but trial ends early
NCT ID NCT06462144
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a single infusion of IMPT-514, a personalized CAR T cell therapy, in 3 adults with severe lupus, vasculitis, or inflammatory myopathy that did not respond to standard treatments. The goal was to check safety and see if the therapy could reset the immune system. The study was terminated early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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3 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
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Zhongshan Hospital Fudan University.
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody aims to wipe out Lupus-Causing immune cells
- Can a single cell therapy calm multiple autoimmune diseases?
- Can a Three-Drug combo quiet lupus kidney flares?
- Can a new antibody tame lupus flares?
- Can a targeted antibody tame kidney inflammation without heavy steroids?
- Can a single infusion of reprogrammed immune cells quiet lupus kidney disease?