Study of Anti-CD19 IL-10IL15 CAR-NK Cell Therapy for Adults with Refractory or Relapsed Autoimmune Diseases Including Lupus, Sclerosis, Myositis, Vasculitis, Sjogrens, and Antiphospholipid Syndrome

What this Trial Is About

Researchers are investigating the safety and effectiveness of Anti-CD19 IL-10IL15 CAR-NK cells in people with difficult-to-treat or relapsed autoimmune diseases. These diseases include systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA-associated vasculitis, Sjogrens syndrome, and antiphospholipid syndrome. This is a single-center, open-label trial designed to evaluate these cells in patients who have not responded well to standard treatments. Participants will receive conditioning treatment with Fludarabine and Cyclophosphamide before being given multiple doses of Anti-CD19 IL-10IL15 CAR-NK cells. These cell infusions occur on Day 0, Day 3, and Day 6. The study includes a dose-escalation phase to assess safety and observe effects at different dose levels. During the trial, researchers will monitor participants for adverse events and dose-limiting toxicities within the first 28 days after infusion and over 12 months. They will also assess disease activity through specific scores and response criteria tailored to each autoimmune condition, such as SLEDAI-2K for lupus and mRSS for systemic sclerosis, over 12 to 48 weeks. Participants will be followed and evaluated regularly to track safety, treatment effects, and disease progression over time.

Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases