Study Evaluating Safety and Effectiveness of CAR NK Cell Injections for Adults with Relapsed or Refractory B-cell Related Autoimmune Diseases

What this Trial Is About

Researchers are studying the safety and effectiveness of CAR NK cells for treating relapsed or refractory B-cell related autoimmune diseases. This early phase 1 pilot study plans to enroll 15 patients to evaluate the safety, feasibility, and potential benefits of this treatment. The study also explores how well the CAR NK cells expand, persist, and deplete B cells in these patients. Participants will receive a pre-treatment of Fludarabine and Cyclophosphamide on days -5, -4, and -3, followed by an infusion of CAR NK cells. This is a single-group, open-label trial where all participants receive the study treatment. The trial monitors patients for adverse events and dose-limiting toxicities within the first 4 weeks and up to 52 weeks after infusion. During the study, participants will be closely monitored through clinical assessments and laboratory tests at multiple time points up to one year after treatment. Researchers will measure safety outcomes including adverse events and toxicities, as well as effectiveness outcomes like disease control and remission rates. The total study duration may last up to approximately three years, including follow-up to assess long-term safety and treatment effects.

A Clinical Study of CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases