Actively Recruiting
A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases
Led by Nanjing Legend Biotech Co. · Updated on 2025-12-04
42
Participants Needed
6
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily provide written informed consent.
- Aged between 18 and 70 years, any gender.
- Must have adequate organ function as determined by screening.
- Must test positive for cluster of differentiation antigen 19 (CD19).
- Diagnosis of systemic lupus erythematosus (SLE) for at least 6 months before screening with positive antinuclear antibody, anti-dsDNA antibody, or anti-Smith antibody, and relapsed/refractory SLE.
- Diagnosis of systemic sclerosis (SSc) before screening with modified Rodnan skin score (mRSS) higher than 10 and relapsed/refractory SSc.
- Diagnosis of antineutrophil cytoplasmic antibody-associated vasculitis (AAV) before screening with positive anti-myeloperoxidase (MPO) and/or p-ANCA or anti-proteinase 3 (PR3) and/or c-ANCA, and relapsed/refractory AAV.
- Diagnosis of idiopathic inflammatory myopathies (IIM) before screening with positive myositis-associated or myositis-specific antibodies and relapsed/refractory IIM.
- Diagnosis of Takayasu arteritis (TAK) before screening with active disease meeting screening criteria and relapsed/refractory TAK.
- Diagnosis of IgG4-related disease (IgG4-RD) before screening with active disease meeting screening criteria and relapsed/refractory IgG4-RD.
You will not qualify if you...
- Active infections such as hepatitis and tuberculosis.
- Presence of other autoimmune diseases besides target conditions.
- Serious underlying diseases including tumors or uncontrolled diabetes.
- Female subjects who are pregnant or breastfeeding.
- History of major organ transplantation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
The Third The People's Hospital of Bengbu
Bengbu, Anhui, China
Actively Recruiting
2
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Not Yet Recruiting
3
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
4
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
5
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
6
The second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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