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NCT Number: NCT06900764

A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, between 18 and 65 years old;
  • Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
  • Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
  • SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
  • Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
  • Good organ functions;
  • Voluntary participates this trial and can comprehend and sign ICF.

Exclusion criteria

  • Had or has active malignancy;
  • Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
  • Combined with other autoimmune disease that needs treatment;
  • Pregnant or lactating women;
  • Has other factors that deemed not suitable by investigator.

Treatment and study plan

CAR-T cell

Drug

CAR-T cell

Primary outcomes

  1. Dose Limiting Toxicity

    Time frame: 0~28 day after treatment

  2. Frequency of AEs, SAEs

    Time frame: 0 day to 24 months after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Qiubai Li, MD/PhD

CONTACT

[email protected]

+86 (027)85726808

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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