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RECRUITING
NCT07193667
NA

CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

Sponsor: ShenZhen Cell Valley

View on ClinicalTrials.gov

Summary

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.

Official title: CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Diseases

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2025-10

Completion Date

2027-12

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

DRUG

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

This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows: 1. Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria. 2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen) 3. Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period. 4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da

Locations (1)

No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province

Shenyang, Liaoning, China