Study of CD19 CAR NK Cell Injection to Treat Relapsed or Refractory Autoimmune Diseases Phase 1 Trial to Evaluate Safety and Effectiveness in Adults

What this Trial Is About

Researchers are studying the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases that have relapsed or are resistant to treatment. This open-label pilot study plans to enroll between 36 and 72 patients to evaluate both the safety and feasibility of this cell therapy. The study also aims to assess how well the treatment works in controlling disease activity. Participants will receive a combination of Fludarabine and Cyclophosphamide chemotherapy drugs on days -5, -4, and -3 before receiving multiple doses of CD19 CAR NK cells. The treatment follows a dose-escalation strategy to carefully increase the cell dose. This trial is a single-arm study without a comparison group, focusing on patients with relapsed or refractory autoimmune diseases. During the study, participants will be closely monitored for up to 48 weeks after infusion to track side effects and treatment-related toxicities. Researchers will assess response rates and disease control at several time points up to 12 months after treatment. Patients will have regular evaluations including blood tests and clinical assessments to measure safety and treatment impact over time.

An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases