NCT07304154

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

A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants With Relapsed/Refractory Autoimmune Neurologic Diseases

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases. The primary objectives of this study are: * To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases * To determine the recommended dose for Phase 1b. * To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy
• Myasthenia Gravis
• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	KITE-363	A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
DRUG	Fludarabine	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-12-26
• Last updated: 2026-03-10

Regulatory

• FDA-regulated drug study