Recruiting
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
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.
ClinicalTrials.gov IDNCT06653556
PhaseEARLY_PHASE1
Enrollment34
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Age18 Years – 65 Years
SexALL
Conditions studied
Systemic Lupus Erythematosus (SLE)
About this study
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.
Interventions
- Biological: LCAR-AIO T cells — Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.
Primary outcomes
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
- Incidence of dose-limiting toxicity (DLT) (30 days after LCAR-AIO infusion (Day 1))
- Pharmacokinetics in peripheral blood (Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
- Recommended Phase 2 Dose (RP2D) regimen finding (Minimum 104 Weeks after LCAR-AIO infusion (Day 1))
Eligibility information
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
Study locations
- Wuhan Union Hospital, Wuhan, Hubei China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-09.