Evaluating KITE-363 CAR T-cell Therapy for Relapsed or Refractory Autoimmune Neurologic Diseases Including Multiple Sclerosis, Myasthenia Gravis, and CIDP

What this Trial Is About

Researchers are studying KITE-363, a CAR T-cell therapy, to evaluate its safety, tolerability, and preliminary effectiveness in adults with relapsed or refractory autoimmune neurologic diseases such as multiple sclerosis MS, myasthenia gravis MG, and chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 1 study includes two parts, Phase 1a and Phase 1b, aimed at determining the recommended dose and assessing safety and early signs of efficacy. Participants with different types of MS, MG, or CIDP will first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of KITE-363 CAR T cells. Dose escalation occurs in Phase 1a to find the best dose for Phase 1b, where that dose is further evaluated. The infusion is given as a single intravenous dose, and participants receive treatments sequentially based on their assigned dose group. During the study, participants will be closely monitored for safety, side effects, and signs of treatment response through various clinical assessments and imaging, including MRI scans for MS and disease-specific scales for MG and CIDP. Blood samples will be taken to measure immune cells, biomarkers, and antibodies. The primary outcomes include monitoring adverse events and treatment-related toxicities over up to two years, along with measures of disease activity and progression. Participants are followed for up to two years to assess treatment effects and safety.

A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases