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

Launched by NANJING LEGEND BIOTECH CO. · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called LUCAR-G79 for adults with certain autoimmune diseases that have returned or not responded to previous treatments. Autoimmune diseases happen when the body’s immune system mistakenly attacks healthy cells. This early-phase study will look at how safe and effective LUCAR-G79 is in people with conditions like lupus (SLE), scleroderma (SSc), vasculitis (AAV), inflammatory muscle diseases (IIM), Takayasu arteritis (TAK), and IgG4-related disease (IgG4-RD). The study is currently not open for new participants.

To join the trial, adults aged 18 to 70 who have been diagnosed with one of these autoimmune diseases and whose condition has either come back or not improved with other treatments may be eligible. Participants must meet specific lab test requirements related to their disease and have healthy enough organs to safely take part. People with active infections, other autoimmune diseases, serious illnesses like cancer, or women who are pregnant or breastfeeding cannot join. Participants can expect to receive different doses of LUCAR-G79 under careful medical supervision to see how well it works and how safe it is. This study aims to find better treatment options for people struggling with these challenging diseases.

Gender

ALL

Eligibility criteria

• 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.