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LUCAR-G79 T cells

Phase 1

Relapsed/Refractory Autoimmune Diseases | Monoclonal antibody | Immunology |Legend Biotech Corporation|Last Updated: Dec 4, 2025

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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07049081A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune DiseasesPHASE1 RECRUITING 42 — — Jul 17, 2025Apr 30, 2030Dec 4, 20256 China
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Study Endpoints
Primary Endpoints
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
2 years after LUCAR-G79 infusion (Day 1)
Incidence of dose-limiting toxicity (DLT)
2 years after LUCAR-G79 infusion (Day 1)
Pharmacokinetics in peripheral blood
2 years after LUCAR-G79 infusion (Day 1)
Recommended Dose regimen finding
2 years after LUCAR-G79 infusion (Day 1)
Secondary Endpoints
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for relapsing/refractory systemic lupus erythematosus (r/r SLE) subjects
52 weeks after LUCAR-G79 infusion (Day 1)
Change in modified Rodnan skin score (mRSS) from baseline up to 52 weeks for relapsing/refractory systemic sclerosis (r/r SSc) subjects
52 weeks after LUCAR-G79 infusion (Day 1)
Change in Birmingham vasculitis activity score (BVAS) from baseline up to 52 weeks for relapsing/refractory anti-neutrophil cytoplastic antibodies (r/r AAV) subjects
52 weeks after LUCAR-G79 infusion (Day 1)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Chimeric antigen receptor T cells (LUCAR-G79)EXPERIMENTALEach subject will be given a single-dose LUCAR-G79 cells infusion at each dose level.
Interventions
NameTypeDescription
LUCAR-G79 T cellsBIOLOGICALPrior to infusion of the LUCAR-G79 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 Sites6

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, 2026NCT07049081primaryCompletionDate: changed
LOWMay 24, 2026NCT07049081studyFirstPostDate: changed