NCT07038447

A Study of KITE-363 in Participants With Refractory Autoimmune 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 Refractory Autoimmune Diseases

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

Summary

This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in participants with refractory autoimmune diseases. The primary objectives of this study are: Phase 1a: To evaluate the safety and tolerability of KITE-363 in participants with autoimmune disease. To determine the recommended dose for Phase 1b. Phase 1b: To evaluate the safety and efficacy of KITE-363 in participants with autoimmune disease.

Conditions

• Systemic Lupus Erythematosus
• Lupus Nephritis
• Systemic Sclerosis
• Idiopathic Inflammatory Myopathy

Interventions

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

Timeline

• Start date: 2025-07-02
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2025-06-26
• Last updated: 2026-04-06

Locations

6 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study