Clinical Trial

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

Enrolling by Invitation Phase 1
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2025-06-18; most recent amendment 2026-06-12.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-07-11
Trial Details
NCT Number NCT07038447
Lead Sponsor Kite, A Gilead Company
Conditions Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
Enrollment 52 participants
Start Date 2025-07-02
Primary Completion 2029-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-16