A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

January 29, 2026 updated by: Nanjing Legend Biotech Co.

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r/r SLE and r/r IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The Third the People's Hospital of Bengbu
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Nanfang Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital of Central South University
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 before screening.
  • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
  • Fulfill relapsed/refractory SLE conditions.

IIM:

  • Have been diagnosed of IIM before screening.
  • Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
  • Fulfill relapsed/refractory IIM conditions.

Exclusion Criteria:

  1. Active infections such as hepatitis and tuberculosis.
  2. Other autoimmune diseases.
  3. Serious underlying diseases such as tumor, uncontrolled diabetes.
  4. Female subjects who were pregnant, breastfeeding.
  5. Those with a history of major organ transplantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chimeric antigen receptor T cells (LUCAR-G79D)
Each subject will be given a single-dose LUCAR-G79D cells infusion at each dose level.
Biological: LUCAR-G79D T cells
Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time Frame: 2 years after LUCAR-G79D infusion (Day 1)
2 years after LUCAR-G79D infusion (Day 1)
Incidence of dose-limiting toxicity (DLT)
Time Frame: 2 years after LUCAR-G79D infusion (Day 1)
2 years after LUCAR-G79D infusion (Day 1)
Maximum concentration (Cmax) in peripheral blood
Time Frame: 2 years after LUCAR-G79D infusion (Day 1)
2 years after LUCAR-G79D infusion (Day 1)
Time of maximum concentration (Tmax) in peripheral blood
Time Frame: 2 years after LUCAR-G79D infusion (Day 1)
2 years after LUCAR-G79D infusion (Day 1)
Area under the concentration-time curve (AUC) in peripheral blood
Time Frame: 2 years after LUCAR-G79D infusion (Day 1)
2 years after LUCAR-G79D infusion (Day 1)
Recommended Dose regimen finding
Time Frame: 2 years after LUCAR-G79D infusion (Day 1)
2 years after LUCAR-G79D infusion (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects
Time Frame: 52 weeks after LUCAR-G79D infusion (Day 1)
SLEDAI-2K is a scale ranging from 0 to 105 points, with higher scores indicating stronger disease activity
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
Time Frame: 52 weeks after LUCAR-G79D infusion (Day 1)
MMT-8 is a scale ranging from 0 to 80 points, with higher scores indicating greater preserved muscle strength
52 weeks after LUCAR-G79D infusion (Day 1)
Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects
Time Frame: 52 weeks after LUCAR-G79D infusion (Day 1)
Including IgG、IgM、IgA、IgE
52 weeks after LUCAR-G79D infusion (Day 1)
Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects
Time Frame: 52 weeks after LUCAR-G79D infusion (Day 1)
52 weeks after LUCAR-G79D infusion (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Legend Biotech Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2030

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB2404D-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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