CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShenZhen Cell Valley

About this trial

In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.

Eligibility criteria

Qualifiers

age 18-65 years (including threshold) and gender;

positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;

Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109/L; b. Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g/L;

Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).

Disqualifiers

A history of severe drug allergies or sensitivities;

the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment

persons with central nervous system disorders caused by ADs or not caused by ADs.

those with intolerable cardiac function;

Trial design

Treatments tested in this trial

  • CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases

Treatment groups

3 Participants
are divided into 1 treatment group

Sponsors and collaborators

ShenZhen Cell Valley

Lead sponsor

First Hospital of China Medical University

Collaborator