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

Inclusion Criteria28

• 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.
• 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.