NCT07490951

Cluster of Differentiation 19 (CD19)/B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases

A Clinical Study on the Safety, Tolerability and Preliminary Efficacy of Targeted CD19/BCMA CAR-T Therapy in the Treatment of Refractory Autoimmune Diseases (ADs)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Genocury Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases.

Detailed description

This open-label, single-arm clinical trial aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases. No lymphodepletion conditioning regimen will be administered in this study. The lentiviral vector drug of CD19/BCMA-targeted CAR-T therapy will be infused directly. Following infusion, subjects will undergo safety and efficacy assessments for up to 24 months to determine whether disease control is achieved.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	CD19/BCMA-targeted CAR-T lentiviral vector drug	The CD19/BCMA-targeted CAR-T lentiviral vector drug is administered intravenously, and autologous CD19/BCMA-targeted CAR-T cells are produced in the patient's body following infusion.

Timeline

• Start date: 2026-03-22
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: China