NCT06711146

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Moderate to Severe Active SLE Clinical Research

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Detailed description

This is a single arm, open-label study. This study is indicated for moderate to severe active systemic lupus erythematosus. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products and our earlier disclosed clinical trials . 1\. Main research objectives: To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of moderate to severe active SLE. 2\. Secondary research objectives: 1. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion and their relationship with the number of B cells. 2. To evaluate the effects of the concentration of autoimmune antibodies and complement after infusion of metabolically armed CD19 CAR-T Cells. 3. To further explore the feasibility and safety of CAR-T therapy regimens without lymphodepletion pretreatment.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Metabolically Armed CD19 CAR-T cells	Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion

Timeline

• Start date: 2024-12-24
• Primary completion: 2026-12-01
• Completion: 2027-04-05
• First posted: 2024-12-02
• Last updated: 2026-03-13

Locations

1 site across 1 country: China