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LUCAR-G79D T cells

Phase 1

Systemic Lupus Erythematosus (SLE) | Monoclonal antibody | Immunology |Legend Biotech Corporation|Last Updated: Feb 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07331272A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)PHASE1 RECRUITING 38Jan 29, 2026Jan 31, 2030Feb 2, 20265 China
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Study Endpoints
Primary Endpoints
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
2 years after LUCAR-G79D infusion (Day 1)
Incidence of dose-limiting toxicity (DLT)
2 years after LUCAR-G79D infusion (Day 1)
Maximum concentration (Cmax) in peripheral blood
2 years after LUCAR-G79D infusion (Day 1)
Time of maximum concentration (Tmax) in peripheral blood
2 years after LUCAR-G79D infusion (Day 1)
Area under the concentration-time curve (AUC) in peripheral blood
2 years after LUCAR-G79D infusion (Day 1)
Recommended Dose regimen finding
2 years after LUCAR-G79D infusion (Day 1)
Secondary Endpoints
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects
52 weeks after LUCAR-G79D infusion (Day 1)
Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for r/r IIM subjects
52 weeks after LUCAR-G79D infusion (Day 1)
Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects
52 weeks after LUCAR-G79D infusion (Day 1)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chimeric antigen receptor T cells (LUCAR-G79D)EXPERIMENTALEach subject will be given a single-dose LUCAR-G79D cells infusion at each dose level.
Interventions
NameTypeDescription
LUCAR-G79D T cellsBIOLOGICALPrior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Subjects voluntary agreement to provide written informed consent. 2. Aged 18 to 70 years, either sex. 3. Adequate organ function meet screening criteria. 4. Positive test for cluster of differentiation antigen 19 (CD19). SLE: * Have been diagnosed of SLE at least 6 months b...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07331272primaryCompletionDate: changed
LOWMay 24, 2026NCT07331272studyFirstPostDate: changed