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

NCT06462144 | Terminated Early Phase 1

• 1 other identifier: RD17-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

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

Keywords

CD19/CD20 CART

Outcome Measures

Primary Outcomes (1)

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

  28 days from cell infusion

Study Arms (1)

Intervention

EXPERIMENTAL

IMPT-514

Drug: IMPT-514 CART Cell Injection

Interventions

IMPT-514 CART Cell Injection DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Any primary immunodeficiency.
• History of, or current significant cardiovascular dysfunction.

Sponsors & Collaborators

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

Study Sites (3)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

The Affiliated Hospital Of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China

Location

Zhongshan Hospital Fudan University.

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Myositis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 17, 2024
• Study Start: June 13, 2024
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)