NCT07315087

CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) 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(QT-019C) 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(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

Detailed description

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells(QT-019C) 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 of cyclophosphamide.Interim analysis will be performed when participants finish the visit at 12 and 24 weeks after CAR T-cell infusion.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	QT-019C	universal allogeneic anti-CD19/BCMA CAR T-cells

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-01-01
• Completion: 2029-01-18
• First posted: 2026-01-02
• Last updated: 2026-01-20

Locations

1 site across 1 country: China