NCT07305116

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.

Detailed description

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

Conditions

• Autoimmune Diseases
• Systemic Lupus Erthematosus (SLE)
• Multi-Drug Resistant Nephrotic Syndrome
• IgA Nephropathy (IgAN)
• Systemic Sclerosis (SSc)
• ANCA Associated Systemic Vasculitis

Interventions

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

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-12-26
• Last updated: 2026-02-03

Locations

1 site across 1 country: China