NCT07059169

CAR-T Therapy for Refractory Autoimmune Diseases

An Exploratory Clinical Study of the Safety, Tolerability, and Initial Efficacy of Targeted Cluster of Differentiation 19 (CD19) CAR-T Therapy for Refractory Autoimmune Diseases

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: LiangZou · Industry
• Sex: All
• Age: 18 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 CAR-T in the treatment of refractory autoimmune diseases.

Detailed description

This open-label, single-arm study aims to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with refractory autoimmune diseases. The study includes two pretreatment regimens: lymphodepletion and non-lymphodepletion. Under the lymphodepletion regimen, after enrollment, patients will undergo leukapheresis followed by 3-5 days of fludarabine and cyclophosphamide lymphodepletion therapy. Subsequently, JY231 injection (CAR-T cell therapy) and autologous Peripheral blood mononuclear cell(PBMC) will be concurrently administered via double-lumen catheter intravenous infusion. The non-lymphodepletion regimen involves direct infusion of JY231 injection without prior lymphodepletion. 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	JY231 (JY231 injection)	JY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China