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LUCAR-G79D

Phase 1

Systemic Lupus Erythematosus (SLE) | Monoclonal antibody | Immunology |Legend Biotech Corporation|Last Updated: Feb 2, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as LUCAR-G79D T cells

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

LUCAR-G79D · 1 trial · 2 indications

Phase 1 1
NCT07331272A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)Systemic Lupus Erythematosus (SLE)
RECRUITING38 Analytics
PHASE1RECRUITING
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
Systemic Lupus Erythematosus (SLE)
NCT0733127238
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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 to 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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Competitive Landscape -Systemic Lupus Erythematosus 94 trials (matched to "Systemic Lupus Erythematosus (SLE)")

Top 20 of 32 competitors

CompanyTickerTrialsLead PhaseDrugs
Biogen Inc.BIIB5PHASE3Litifilimab
Bristol-Myers Squibb CompanyBMY7PHASE3Deucravacitinib
Viatris, Inc.VTRS5PHASE3Cenerimod
Novartis AG Sponsored ADRNVS7PHASE3Ianalumab
AstraZeneca PLCAZN21PHASE3Medi-546
Johnson & JohnsonJNJ1PHASE3Nipocalimab
AbbVie, Inc.ABBV2PHASE3Upadacitinib
GSK plc Sponsored ADRGSK3PHASE2Belimumab
Sanofi SA Sponsored ADRSNY2PHASE2SAR441344
Zenas BioPharma, Inc.ZBIO1PHASE2Obexelimab
Alumis Inc.ALMS1PHASE2Envudeucitinib
Immunovant IncIMVT1PHASE2IMVT-1402
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Fate Therapeutics, Inc.FATE2PHASE2FT819
Eli Lilly and CompanyLLY1PHASE1LY4298445
Cartesian Therapeutics, Inc.RNAC2PHASE2Descartes-08
Merck & Co., Inc.MRK1PHASE1MK-1045
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Artiva Biotherapeutics, Inc.ARTV2PHASE1AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
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