Study of Safety and Effectiveness of Universal CD19 CAR-T Therapy for Recurrent or Hard-to-Treat Autoimmune Diseases in Adults

What this Trial Is About

Researchers are evaluating the safety and initial effectiveness of universal CD19 CAR-T therapy in adults with recurrent or refractory autoimmune diseases. This exploratory clinical trial uses a traditional dose escalation design to carefully observe dose limiting toxicities DLTs and establish a maximum tolerated dose. The study aims to provide important early data on how this genetic treatment may work for these challenging autoimmune conditions under medical supervision. Participants will receive one of three doses of CD19 CAR-T cells, starting at 0.5 million CAR T cells per kilogram of body weight, with doses increasing based on safety observations. The trial follows a 33 dose escalation method, enrolling small groups at each dose level and monitoring closely for adverse effects. If toxicities occur, adjustments are made including adding more participants or lowering doses. After treatment, participants are followed for 24 months to monitor safety and gather preliminary effectiveness data. Throughout the study, participants will undergo regular safety assessments focused on detecting dose limiting toxicities within the first 28 days after treatment. They will be monitored closely for side effects and health changes. The trial includes detailed eligibility screening based on diagnosis and disease activity, along with laboratory tests and clinical evaluations to ensure suitability and safety. Participants will be observed for up to two years after infusion to evaluate longer-term safety and treatment outcomes.

Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases