NCT07361094

Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases

An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19-BCMA Dual-Target Chimeric Antigen Receptor T-Cell Therapy in Patients With Relapsed or Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and damage to organs such as the kidneys, lungs, muscles, nerves, or blood cells. Although many treatments are available, some patients do not respond adequately or experience repeated disease flares despite long-term therapy. New treatment approaches are therefore needed for patients with relapsed or refractory autoimmune diseases. This study is an exploratory clinical trial designed to evaluate the safety and potential benefits of a novel cell-based therapy called autologous CD19-BCMA dual-target CAR T-cell therapy. This treatment uses a patient's own immune cells, which are collected from the blood, modified in the laboratory to recognize specific immune cells involved in autoimmune disease, and then infused back into the patient. The study includes adult patients with certain relapsed or refractory autoimmune diseases, such as systemic lupus erythematosus, systemic sclerosis, inflammatory muscle diseases, Sjögren's syndrome, autoimmune hemolytic anemia, and multiple sclerosis. After cell collection and preparative treatment, participants will receive a single infusion of the investigational CAR T-cell therapy and will be closely monitored for safety. The main purpose of this study is to better understand the safety of this treatment, including possible side effects. The study will also explore how the disease responds to treatment over time. Participants will be followed for up to two years after treatment to assess safety and clinical outcomes. The results of this study may help researchers better understand whether this type of cell therapy could be a feasible treatment option for patients with difficult-to-treat autoimmune diseases in the future.

Conditions

• Relapsed/Refractory Systemic Lupus Erythematosus
• Relapsed/Refractory Systemic Sclerosis
• Relapsed/Refractory Idiopathic Inflammatory Myopathies
• Relapsed/Refractory sjögren's Syndrome
• Relapsed/Refractory Autoimmune Hemolytic Anemia
• Relapsed/Refractory Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy	Autologous CD19-BCMA dual-target CAR T-cell therapy is a personalized cell-based immunotherapy manufactured from each participant's own peripheral blood T lymphocytes. Following leukapheresis, autologous T cells are genetically modified ex vivo to express a chimeric antigen receptor targeting both CD19 and B-cell maturation antigen (BCMA), enabling recognition and elimination of B-lineage cells and antibody-producing plasma cells implicated in autoimmune disease pathogenesis. The modified T cells are expanded under controlled conditions and administered as a single intravenous infusion after lymphodepleting conditioning. This dual-target CAR-T approach is intended to provide broad and sustained depletion of pathogenic B-cell populations and to promote immune system rebalancing in patients with relapsed or refractory autoimmune diseases.

Timeline

• Start date: 2025-11-06
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China