A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
Recruiting · NCT07331272 · Interventional (participants receive a specific treatment) · Lead sponsor: Nanjing Legend Biotech Co.
View the official record on ClinicalTrials.gov →Interventions studied
LUCAR-G79D T cells
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- 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.
Exclusion criteria
- 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.
Where it is running
5 locations listed.
- The Third The People's Hospital of Bengbu - Bengbu, Anhui, China
- Nanfang Hospital - Guangzhou, Guangdong, China
- Xiangya Hospital of Central South University - Changsha, Hunan, China
- The Affiliated Hospital of Xuzhou Medical University - Xuzhou, Jiangsu, China
- The First Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China