Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07040917

A Study of CAR-T Cells in Subjects With Autoimmune Diseases

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

This is a single center, one-arm, open label study aiming to evaluate the safety and efficacy of CAR-T cells therapy in subjects with autoimmune diseases.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Male or female, between 18 and 65 years old;
  • Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia, Pemphigus;
  • Good organ functions;
  • Subjects must understand and personally, voluntarily sign and date an informed consent.

Key Exclusion Criteria:

  • Had or has active malignancy;
  • Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products;
  • Combined with other autoimmune disease that needs systemic treatment or therapy;
  • 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 adverse events, serious adverse events

    Time frame: within 24 months after treatment

Study contacts

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

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Autoimmune Diseases

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 27, 2025
Registry last updated
Jul 20, 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.

Published trials that share one or more normalized conditions with this study.