NCT06680388

CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases

Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Autoimmune diseases such as systemic lupus erythematosus (SLE), diffuse cutaneous systemic sclerosis (dcSSc), antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and Sjogren's syndrome (SS) have complex etiologies and are prone to cause systemic multiple organ damage. Because patients need lifelong medication due to repeated disease recurrence, and the current treatment of the above autoimmune diseases has limited efficacy and greater side effects, so that patients bear an excessive burden of disease, therefore, there is an urgent need to explore safer and more effective treatment. Several autologous CAR-T products targeting CD19 have been marketed for the treatment of B-cell hematological malignancies. Depletion of B cells to suppress abnormal immune responses is also currently one of the popular strategies for the treatment of antibody-mediated autoimmune diseases, and many clinical studies of CAR-T against autoimmune diseases are still ongoing. Therefore, a dose escalation trial is planned to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T in patients with relapsed/refractory autoimmune diseases.

Detailed description

This study is a single-center, open, exploratory clinical trial designed to evaluate the safety and efficacy of autologous CD19 CAR-T in the treatment of relapsed/refractory autoimmune disease. The study will adopt the traditional dose escalation model "3+3" design, set up 3 dose groups, with 0.5×10\^6 CAR+T cells /kg as the initial dose to increase, observe DLT, and conduct a 24-month safety and efficacy follow-up after cell infusion to observe the safety of autologous CD19 CAR-T. At the same time, preliminary efficacy evaluation was carried out.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	Drug：CD19 CAR-T	A total of 3 dose groups were set, with dose group 1 as the starting dose, which was performed according to the traditional 3 + 3 design rule as a single intravenous infusion.

Timeline

• Start date: 2024-11-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-11-08
• Last updated: 2025-12-24

Locations

1 site across 1 country: China