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TerminatedNCT06462144Updated Jan 28, 2026

IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy

An Early Phase 1 interventional study of IMPT-514 CART Cell Injection in Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV) and Idiopathic Inflammatory Myopathy (IIM), sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Terminated at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Early Phase 1, Interventional, and Treatment

Why this study was terminated
The collaborating party has adjusted its R\&D strategy and terminated the study.
Phase
Early Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

This study will explore the safety of IMPT-514 and will include up to two dose levels, with up to 12 total expected dosed participants for each disease group of SLE, AAV, and IIM.

IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 2 year from IMPT-415 administration.

02

Conditions studied

  • Systemic Lupus Erythematosus (SLE)
  • ANCA Associated Vasculitis (AAV)
  • Idiopathic Inflammatory Myopathy (IIM)

Keywords

  • CD19/CD20 CART
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Intervention

    IMPT-514

    Drug: IMPT-514 CART Cell Injection

Interventions

  • DrugIMPT-514 CART Cell Injection

    CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

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What researchers measure

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs), serious adverse events (SAE) and treatment-emergent adverse events (TEAEs).

    Time frame: 28 days from cell infusion

07

Study locations

3 sites
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
  • The Affiliated Hospital Of Xuzhou Medical University
    Xuzhou, Jiangsu 221004, China
  • Zhongshan Hospital Fudan University.
    Shanghai, Shanghai Municipality 200032, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06462144
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party
Lingyun Sun (Chief physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School) — Principal investigator
First posted
Jun 17, 2024
Start date
Jun 13, 2024
Primary completion
Oct 21, 2025
Completion
Oct 21, 2025
Last update
Jan 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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