RecruitingNot ApplicableNCT06614270

Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases

Clinical Study of Core Blood-derived Anti-CD19 IL-10/IL15 CAR-NK in the Treatment of Refractory/Relapsed Autoimmune Diseases

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

15 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus Sjogren's Syndrome Systemic Sclerosis (SSc)Antiphospholipid Syndrome Idiopathic Inflammatory Myopathy (IIM)ANCA Associated Vasculitis (AAV)

Summary

This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Anti-CD19 IL-10/IL15 CAR-NK for people with anca associated vasculitis (aav), antiphospholipid syndrome, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnti-CD19 IL-10/IL15 CAR-NK

Patients will receive Fludarabine and Cyclophosphamide for conditioning. Multiple doses of Anti-CD19 IL-10/IL15 CAR-NK cells will be infused on Day 0, 3, and 6.