A Clinical Study of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title: A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 Universal CAR-γδT Cells in Active Systemic Lupus Erythematosus

Status Recruiting

Clinical Trial Summary

The purpose of the study is to explore the safety and efficacy of CD19 Universal CAR-γδT cells in active severe systemic lupus erythematosus.

Clinical Trial Description

The prognosis of patients with active systemic lupus erythematosus (SLE) remains poor, due to two major therapeutic obstacles: (1) current treatment strategies including glucocorticoids, immunosuppressive agents, biological agents, are still difficult to achieve disease control, making the disease condition of some patients continue to be active or even worse; (2) some patients are unable to wean themselves off glucocorticoid and face the risk of numerous adverse effects caused by long-term glucocorticoid dependence, such as glucocorticoid-related diabetes, femoral head necrosis, hypertension, stress ulcers, and infection, etc. Therefore, there is a strong unmet clinical need for more effective treatment for patients suffering from active SLE. Several preclinical studies have shown the efficacy of CAR-T cell treatment in SLE. The aim of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of CD19 Universal CAR-γδT cells therapy in active SLE. Patients with active SLE will be invited to participate in the study, to receive CD19 Universal CAR-γδT cells intravenous infusion and follow-up visits of up to 2 years after enrollment. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT06106893
• Study type: Interventional
• Source: Wuhan Union Hospital, China
• Contact: Qiubai Li, Professor
• Phone: 85726808
• Email: qiubaili@hust.edu.cn
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 12, 2024
• Completion date: December 2026