NCT07161193

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases

Detailed description

This is a single-center, open-label, single-arm, dose-escalation trial. In this study, we will recruit seven kinds of refractory autoimmune diseases including moderate-to-severe Systemic lupus erythematosus (SLE), refractory Pemphigus, refractory Idiopathic inflammatory myopathy (IIM), Systemic sclerosis (SSc), Refractory ANCA-Associated Vasculitis/Nephritis,refractory Rheumatoid arthritis(RA) and moderate-to-severe refractory Psoriasis. Patients with Refractory Autoimmune Diseases will receive CD19 CAR T cells. The primary objective is to evaluate the safety and efficacy of CD19 CAR T cell therapy in subjects with Refractory Autoimmune Diseases and to determine the optimal biological dose (OBD) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with Refractory Autoimmune Diseases in phase II. The primary endpoint is to evaluate the incidence and severity of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.A total number of 3o subjects will be enrolled.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR-T cells	Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-08-18
• Completion: 2027-11-18
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: China