NCT06941129

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

Detailed description

This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit 12 and 24 weeks after CAR T-cell infusion.

Conditions

• Systemic Lupus Erythematosus
• Systemic Sclerosis (SSc)
• Inflammatory Myopathy
• ANCA-Associated Vasculitis (AAV)
• Connective Tissue Disease-Associated Thrombocytopenia
• SLE-ITP

Interventions

Type	Name	Description
BIOLOGICAL	UCAR T-cell	universal allogeneic anti-CD19/BCMA CAR T-cells

Timeline

• Start date: 2025-02-11
• Primary completion: 2028-02-18
• Completion: 2028-03-18
• First posted: 2025-04-23
• Last updated: 2025-09-29

Locations

1 site across 1 country: China