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

Launched by CHINESE PLA GENERAL HOSPITAL · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CAR-T cell therapy for people with autoimmune diseases. Autoimmune diseases happen when the immune system, which normally protects the body, mistakenly attacks healthy cells. This study aims to find out if this therapy is safe and if it can help manage these conditions.

To join the trial, participants need to be adults between 18 and 65 years old who have been diagnosed with certain autoimmune diseases like lupus, scleroderma, or Sjögren's syndrome. They must have good overall health and be able to understand and agree to take part in the study. People who have had cancer recently, received similar treatments before, have other autoimmune diseases needing treatment, or are pregnant won’t be eligible. Although the study is not yet recruiting participants, those who join will receive CAR-T cell therapy, and researchers will carefully watch how their bodies respond to see if the treatment is safe and effective.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Male or female, between 18 and 65 years old;
• • 2. 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；
• • 3. Good organ functions;
• • 4. Subjects must understand and personally, voluntarily sign and date an informed consent.
• Key Exclusion Criteria:
• • 1. Had or has active malignancy;
• • 2. Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products;
• • 3. Combined with other autoimmune disease that needs systemic treatment or therapy;
• • 4. Pregnant or lactating women;
• • 5. Has other factors that deemed not suitable by investigator.