Actively Recruiting
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
Led by Nanjing Legend Biotech Co. · Updated on 2026-02-02
38
Participants Needed
5
Research Sites
209 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-G79D in adult subjects with r/r SLE and r/r IIM.
CONDITIONS
Official Title
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
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.
- Have adequate organ function as determined by screening.
- Positive test for cluster of differentiation antigen 19 (CD19).
- For SLE subjects: diagnosed at least 6 months before screening, positive for antinuclear antibody and/or anti-dsDNA antibody and/or anti-Smith antibody at screening, and meet relapsed/refractory SLE criteria.
- For IIM subjects: diagnosed before screening, positive for myositis-associated or myositis-specific antibodies at screening, and meet relapsed/refractory IIM criteria.
You will not qualify if you...
- Have active infections such as hepatitis or tuberculosis.
- Have other autoimmune diseases.
- Have serious underlying diseases such as tumors or uncontrolled diabetes.
- Female subjects who are pregnant or breastfeeding.
- History of major organ transplantation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Third The People's Hospital of Bengbu
Bengbu, Anhui, China
Actively Recruiting
2
Nanfang Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
4
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
5
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet 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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