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

NCT06462144 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-01-28

No results posted yet for this 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).

Conditions

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

Interventions

DRUG

IMPT-514 CART Cell Injection

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2025-10-21
Completion
2025-10-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06462144 on ClinicalTrials.gov