A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
Recruiting · NCT06653556 · Interventional (participants receive a specific treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
View the official record on ClinicalTrials.gov →Interventions studied
LCAR-AIO T cells
What this trial is about
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
1. Subjects voluntarily participate in clinical research.
2. Age 18-65 years.
3. Have been diagnosed of SLE at least 6 months before screening.
4. At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.
5. Fulfill relapsed/refractory SLE conditions.
6. Adequate organ function at screening.
7. Clinical laboratory values meet criteria at screening.
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, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
5. Participated in other clinical trials within
Where it is running
1 location listed.
- Wuhan Union Hospital - Wuhan, Hubei, China