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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Autoimmune Diseases

Treatments: Drug: CAR-T cell

Study type: Interventional

Funder types: Other

Identifiers

NCT07040917

AID01

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

CAR-T treatment

Experimental group

Treatment:

Drug: CAR-T cell