NCT06106906

A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus

A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 CAR-T in Active Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 CAR-T cell therapy in active SLE. Patients with active SLE will be invited to participate in the study, to receive CD19 CAR-T intravenous infusion and follow-up visits of up to 2 years after enrollment.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR-T cell infusion	CD19 CAR-T cell intravenous infusion

Timeline

• Start date: 2024-06-19
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2023-10-30
• Last updated: 2025-01-08

Locations

1 site across 1 country: China