A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-G79 in adult subjects with relapsed/refractory autoimmune diseases.

Study Overview

• Status: Terminated
• Conditions: Relapsed/Refractory Autoimmune Diseases
• Intervention / Treatment: Biological: LUCAR-G79 T cells

Detailed Description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LUCAR-G79 infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79 infusion) and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The Third The People's Hospital of Bengbu
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University
  • Shanxi
    • Xi’an, Shanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

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.

SSc:

• Have been diagnosed of SSc before screening.
• At screening, mRSS is higher than 10.
• Fulfill relapsed/refractory SSc conditions.

AAV:

• Have been diagnosed of AAV before screening.
• Antineutrophil Cytoplasmic Antibody (ANCA)-related antibodies meet one of the following conditions: a. Positive for anti-myeloperoxidase (MPO) and/or p-ANCA; b. Positive for anti-proteinase 3 (PR3) and/or c-ANCA.
• Fulfill relapsed/refractory AAV 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.

TAK:

• Have been diagnosed of TAK before screening.
• Active TAK patients meet screening criteria.
• Fulfill relapsed/refractory TAK conditions.

IgG4-RD:

• Have been diagnosed of IgG4-RD before screening.
• Active IgG4-RD patients meet screening criteria.
• Fulfill relapsed/refractory IgG4-RD 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chimeric antigen receptor T cells (LUCAR-G79); Each subject will be given a single-dose LUCAR-G79 cells infusion at each dose level.	Biological: LUCAR-G79 T cells; Prior to infusion of the LUCAR-G79 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)	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 Outcome Measures

Outcome Measure	Time Frame
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)
Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for relapsing/refractory idiopathic inflammatory myopathy (r/r IIM) subjects	52 weeks after LUCAR-G79 infusion (Day 1)
Change in Indian Takayasu Activity Score with the Acute-Phase Response (ITAS.A) from baseline up to 52 weeks for relapsing/refractory takayasu arteritis (r/r TAK) subjects	52 weeks after LUCAR-G79 infusion (Day 1)
Change in Immune globulin G4-related diseases Response Index (IgG4-RD RI) from baseline up to 52 weeks for relapsing/refractory Immune globulin G4-related diseases (r/r IgG4-RD) subjects	52 weeks after LUCAR-G79 infusion (Day 1)
Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody) from baseline up to 52 weeks for all subjects	52 weeks after LUCAR-G79 infusion (Day 1)

Collaborators and Investigators

• Sponsor: Nanjing Legend Biotech Co.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Actual): March 20, 2026
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 3, 2025

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: LB2404-0001

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