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LUCAR-G79D

Phase 1

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

LUCAR-G79D 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

LUCAR-G79D clinical trials

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)Unlock trial analytics

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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Frequently asked questions about LUCAR-G79D

What is LUCAR-G79D?

LUCAR-G79D is an investigational cell therapy being developed by Legend Biotech Corporation for relapsed or refractory systemic lupus erythematosus (SLE) and idiopathic inflammatory myopathies (IIM). It is also known as LUCAR-G79D T cells. It is currently in Phase 1 clinical development and has not been approved for any indication.

What is LUCAR-G79D used for?

LUCAR-G79D is being studied for the treatment of relapsed or refractory systemic lupus erythematosus (SLE) and idiopathic inflammatory myopathies (IIM). These are autoimmune conditions, and the trial enrolls patients whose disease has not responded to prior therapy. The drug remains investigational and is not approved for any use.

Who makes LUCAR-G79D?

LUCAR-G79D is being developed by Legend Biotech Corporation, which trades under the ticker LEGN. Legend Biotech is the sponsor of the Phase 1 study evaluating the therapy in autoimmune indications.

What phase is LUCAR-G79D in?

LUCAR-G79D is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The single ongoing study is currently recruiting participants, and no trials of LUCAR-G79D have been completed.

What clinical trials is LUCAR-G79D in?

LUCAR-G79D is being evaluated in one Phase 1 trial, NCT07331272, titled A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM). The study is recruiting, is uncontrolled, and plans to enroll 38 participants in China.

Is LUCAR-G79D the same as LUCAR-G79D T cells?

Yes, LUCAR-G79D T cells is another name for LUCAR-G79D. Both names refer to the same investigational therapy developed by Legend Biotech Corporation for relapsed or refractory systemic lupus erythematosus and idiopathic inflammatory myopathies.