NCT06691152

Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus

Efficacy and Safety Study of CD19 Universal CAR T Cells in Refractory Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of CD19 Universal CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Detailed description

Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death. Children with SLE are particularly at risk of organ damage, especially to the kidneys, and tend to have a more severe and protracted course of the disease compared to adults. Since 2019, CAR T-cell therapy has been successfully applied to autoimmune diseases. Clinical studies have demonstrated that targeted auto-CD19 CAR T-cells hold significant therapeutic potential for SLE. These cells effectively slow down the pathological progression of SLE and can also effectively treat severe cases. However, there are many limitations to the wide application of autologous CAR T-cells, autologous CAR T-cells are "personalized" products, which take a long time to produce, and their quality is affected by the patient's own physique, which is not conducive to scale and standardization. Besides, due to the personalized and complex preparation process of autologous CAR-T cell products, the costs are quite high which limits the promotion of use in the population. Compared with autologous CAR-T cell product, universal CAR-T cell products derived from healthy donors, it is not affected by the quantity and quality of the patient's T cells, leading to a high success rate in preparation. A single batch can meet the needs of hundreds of people, offering absolute advantages in time and cost. Compared to traditional autologous CAR-T cells, allogeneic universal CAR T-cells can greatly expand the accessibility of the product to patients, benefiting more patients. The purpose of this study is to assess the safety and efficacy of the CD19 universal CAR-T cells in the treatment of refractory SLE.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	CD19 Universal CAR-T cells	Three dose groups (1×10\^7/kg, 3×10\^7/kg, 6×10\^7/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.

Timeline

• Start date: 2024-10-30
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: China