NCT06794008

BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases

An Open, Single-Arm, Single-Center Clinical Study Assessing the Safety and Efficacy of BCMA-CD19 Targeted Chimeric Antigen Receptor T-Cell Therapy in Multiple Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.

Detailed description

The investigators designed a single-center, open-label, single-arm clinical study. Adults with multiple refractory autoimmune diseases will be enrolled, meeting the inclusion criteria. BCMA-CD19 targeted chimeric antigen receptor T-cells will be administered intravenously 1-2 days after preconditioning, at a dose of 3×10\^6/kg of CAR-T cells per kilogram (referring to successfully transduced CAR-T cells, not total T cells). The total volume of the CAR-T cell suspension administered per patient will range from approximately 10 to 70 mL, using a "single-dose" regimen. The entire dose of CAR-T cells will be infused intravenously rapidly on day 0. Patients will be evaluated for improvements in clinical and laboratory parameters to assess the safety and efficacy of BCMA-CD19 CAR-T therapy. The primary endpoints include the Complete Remission Rate and laboratory indicators. Secondary endpoints include pharmacokinetic characteristics, long-term efficacy, and safety.

Conditions

• Systemic Lupus Erythematosus
• Inflammatory Myopathy
• Systemic Sclerosis (SSc)
• ANCA-associated Vasculitis
• IgG4-Related Diseases
• Antiphospholipid Syndrome
• Acquired Thrombotic Thrombocytopenic Purpura
• Behcet Disease
• Sjogren Syndrome

Interventions

Type	Name	Description
DRUG	BCMA-CD19 CAR-T therapy	Patients received the BCMA-CD19-targeted CAR-T cells with a dosage of 3×10\^6/kg CAR-T cells per kilogram.

Timeline

• Start date: 2024-12-26
• Primary completion: 2027-12-30
• Completion: 2027-12-31
• First posted: 2025-01-27
• Last updated: 2025-04-02

Locations

1 site across 1 country: China