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KITE-363

Phase 1

Systemic Lupus Erythematosus | Monoclonal antibody | Immunology |Gilead Sciences, Inc.|Last Updated: Apr 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07038447A Study of KITE-363 in Participants With Refractory Autoimmune DiseasesPHASE1 ENROLLING BY_INVITATION 52 — — Jul 2, 2025Jul 1, 2029Apr 6, 20266 United States, Australia +1
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Study Endpoints
Primary Endpoints
Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363
Up to 2 years
Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Up to 2 years
Phase 1b: Systemic lupus erythematosus (SLE): Proportion of participants meeting DORIS remission and Lupus low Disease Activity State (LLDAS) criteria at Month 6
Month 6
Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission
Month 6
Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6
Month 6
Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants With Improvement in Disease Activity by the Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) at Month 6
Month 6
Phase 1b: Idiopathic Inflammatory Myopathy (IIM): Proportions of Participants Meeting European League Against Rheumatism (EULAR)-American College of Rheumatology (ACR) Moderate and Major response 2016 Criteria in Total Improvement Score (TIS) at Month 6
Month 6
Secondary Endpoints
Characterization of Product, Including T-cell Phenotype as Assessed by Percent Change From Baseline in cluster of differentiation 3 (CD3)+ Cells and T Cells
Baseline up to 2 years
Pharmacokinetic parameter: Serum Concentration of KITE-363 CAR T-cells
Up to 2 years
Pharmacokinetic parameter: Peak Concentration (Cmax) for KITE-363 CAR T-cells
Up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: KITE-363 (Dose Escalation)EXPERIMENTALParticipants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by 2 dose escalations of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells to find the Phase 1b recommended dose.
Phase 1b: KITE-363 (Dose Expansion)EXPERIMENTALParticipants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1ab recommended dose of KITE-363 CAR T cells.
Interventions
NameTypeDescription
KITE-363BIOLOGICALA single infusion of CAR-transduced autologous T cells administered intravenously
FludarabineDRUGAdministered intravenously
CyclophosphamideDRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN): * Age ≥ 18 years * Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE * Presence of either doubl...

Countries:United StatesAustraliaCanada
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Competitive Landscape -Systemic Lupus Erythematosus 94 trials
CompanyTickerTrialsLead PhaseDrugs
Biogen Inc.BIIB5PHASE3Litifilimab, BIIB059
Viatris, Inc.VTRS5PHASE3Cenerimod, cenerimod
Bristol-Myers Squibb CompanyBMY7PHASE3Deucravacitinib, Afimetoran, CC-97540, Fludarabine, Cyclophosphamide
Novartis AG Sponsored ADRNVS7PHASE3Ianalumab, ianalumab, VAY736 PFS, VAY736 AI, rapcabtagene autoleucel
AstraZeneca PLCAZN21PHASE3Medi-546, Anifrolumab, AZD0120, Cyclophosphamide, Fludarabine
AbbVie, Inc.ABBV2PHASE3Upadacitinib, ABBV-319
Johnson & JohnsonJNJ1PHASE3Nipocalimab
GSK plc Sponsored ADRGSK3PHASE2Belimumab, GSK4527363, GSK5926371
Sanofi SA Sponsored ADRSNY2PHASE2SAR441344, SAR448501
Alumis Inc.ALMS1PHASE2Envudeucitinib
Zenas BioPharma, Inc.ZBIO1PHASE2Obexelimab
Immunovant IncIMVT1PHASE2IMVT-1402
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Fate Therapeutics, Inc.FATE2PHASE2FT819, Fludarabine, Cyclophosphamide, Bendamustine
Eli Lilly and CompanyLLY1PHASE1LY4298445
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Merck & Co., Inc.MRK1PHASE1MK-1045
Cartesian Therapeutics, Inc.RNAC2PHASE2Descartes-08
Artiva Biotherapeutics, Inc.ARTV2PHASE1AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab
CRISPR Therapeutics AGCRSP1PHASE1CTX112
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07038447primaryCompletionDate: changed
LOWMay 24, 2026NCT07038447studyFirstPostDate: changed