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Experimental CAR t therapy targets lupus and related diseases – but trial ends early

NCT ID NCT06462144

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

3 people

The number who actually took part.

Started

Jun 2024

Finished

Oct 2025

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • The Affiliated Hospital Of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004, China

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • Zhongshan Hospital Fudan University.

    Shanghai, Shanghai Municipality, 200032, China

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