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

StatusEnrolling by Invitation
PhasePhase 1
Started2025-07-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later Jul 2029 → Sep 2030
See other at-risk trials from Gilead Sciences

Amendment history

2026-09-29
Primary completion pushed: 2029-07 → 2030-09
Completion pushed: 2029-07 → 2030-09
2026-06-12
Study Status, Contacts/Locations v6
Study sites6→8
2026-04-03
Study Status, Contacts/Locations v5
Study sites5→6
2026-03-12
Study Status, Outcome Measures, Eligibility v4
Eligibility criteria+27 characters
Key Inclusion Criteria: Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN): Age ≥ 18 and ≤ 75 years Meet the European Alliance of Associations for Rheumat [...] g Inclusion Criteria for systemic sclerosis (SSc): Age ≥ 18 and ≤ 60 years EarlyDiffuse systemicSystemic sclerosisSclerosis (SSc) according to ACR/EULAR 2013 classification criteria with active skin disease and/or progressive SSc-interstitial lung disease (ILD) OR limited SSc with progressive ILD. Refractory or intolerance to 1 of the following for a minim [...] onary function test (PFT) within 3 months prior to scree [...]
Primary endpoints7 entries, revised
Phase 1b: Idiopathic Inflammatory Myopathy (IIM): Proportions of Participants Meeting European League Agains [...] teria in Total Improvement Score (TIS) at Month 6 Phase 1b: Lupus Nephritis (LN): Proportion of Participants Achieving a Complete Renal Response at Month 6 Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants With Progressive Interstitial Lung Disease (ILD), no Worsening of Pulmonary Function at Month 6 Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants with Improvement [...] [...]
2026-01-09
Study Status, Contacts/Locations v3
Study sites3→5
Show 2 earlier versions
2025-12-12
Study Status, Contacts/Locations v2
Study sites1→3
2025-07-11
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2025-07→confirmed 2025-07-02
Study sites0→1
2025-06-18
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
Lupus (SLE)
648 trials monitored
See 25 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
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.
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 2030-09 (estimated)
Study Completion 2030-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-28