Recent Updates
Recently added Catalysts

LUCAR-G79D T cells

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

LUCAR-G79D T cells · 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)
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about LUCAR-G79D T cells

What is LUCAR-G79D T cells used for?

LUCAR-G79D T cells is an investigational cell therapy being studied for the treatment of relapsed/refractory Systemic Lupus Erythematosus (SLE) and Idiopathic Inflammatory Myopathies (IIM). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing LUCAR-G79D T cells?

LUCAR-G79D T cells is being developed by Legend Biotech Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker LEGN. The company is conducting a Phase 1 clinical trial of this investigational therapy in China.

What phase is LUCAR-G79D T cells in?

LUCAR-G79D T cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is LUCAR-G79D T cells in?

LUCAR-G79D T cells is being studied in a Phase 1 clinical trial identified as NCT07331272. This trial is recruiting participants with relapsed/refractory Systemic Lupus Erythematosus and Idiopathic Inflammatory Myopathies, with an enrollment target of 38 participants in China.

Is LUCAR-G79D T cells FDA approved?

LUCAR-G79D T cells is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development, meaning it has not yet been approved by the FDA or any other regulatory authority for commercial use.