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

NCT07049081 | Recruiting Phase 1

• 1 other identifier: LB2404-0001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Relapsed/Refractory Autoimmune Diseases

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• 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)

Study Arms (1)

Chimeric antigen receptor T cells (LUCAR-G79)

EXPERIMENTAL

Each subject will be given a single-dose LUCAR-G79 cells infusion at each dose level.

Biological: LUCAR-G79 T cells

Interventions

LUCAR-G79 T cells BIOLOGICAL

Prior to infusion of the LUCAR-G79 T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Chimeric antigen receptor T cells (LUCAR-G79)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntary agreement to provide written informed consent.
• Aged 18 to 70 years, either sex.
• Adequate organ function meet screening criteria.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing Legend Biotech Co.: lead

Study Sites (6)

The Third The People's Hospital of Bengbu

Bengbu, Anhui, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

NOT YET RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

The second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 3, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)