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YTB323

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |Novartis AG|Last Updated: Jun 2, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05798117An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus ErythematosusPHASE1 ACTIVE NOT_RECRUITING 21Feb 28, 2023Sep 24, 2026Jun 2, 202610 Australia, France +3
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Study Endpoints
Primary Endpoints
Number of participants with AEs and SAEs
Day 1 to 2 years

Long term safety follow up

Secondary Endpoints
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Maximum observed blood concentration Cmax)
Pre-dose, up to 2 years
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Area under plasma concentration -time AUC)
Pre-dose, up to 2 years
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach maximum concentration Tmax)
Pre-dose, up to 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
YTB323EXPERIMENTALSingle infusion of YTB323
Interventions
NameTypeDescription
YTB323DRUGSingle infusion of YTB323
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Signed informed consent * Adequate renal, hepatic, cardiac, hematological and pulmonary function * Men and women with SLE, aged ≥18 years and ≤65 years at screening, fulfilling the 2019 European League Against Rheumatism EULAR/ACR classification criteria for SLE. * Patient mus...

Countries:AustraliaFranceGermanySpainSwitzerland
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT05798117primaryCompletionDate: changed
LOWJun 2, 2026NCT05798117primaryCompletionDate: changed
LOWJun 2, 2026NCT05798117primaryCompletionDate: changed
LOWMay 26, 2026NCT05798117primaryCompletionDate: changed
LOWMay 24, 2026NCT05798117studyFirstPostDate: changed