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

Not Applicable

Not yet recruiting

• Conditions: Autoimmune Diseases
• Interventions: Drug: CAR-T cell

• Registration Number: NCT07040917
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-20
• Study Start: 2025-09-30
• Primary Completion: 2027-11-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T treatment	CAR-T cell	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	0~28 day after treatment
Frequency of adverse events, serious adverse events	within 24 months after treatment

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China