Actively Recruiting
Study to Evaluate LCAR-AIO T Cell Therapy for Adults with Relapsed or Refractory Systemic Lupus Erythematosus Open-Label, Single-Arm Study Assessing Safety, Tolerability, and Effects
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-01-10
34
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
N
Nanjing Legend Biotech Co.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating LCAR-AIO, a chimeric antigen receptor (CAR) T cell therapy, in adults with relapsed or refractory systemic lupus erythematosus (SLE). This open-label, single-arm study aims to explore the safety, tolerability, pharmacokinetics, and efficacy of LCAR-AIO in this patient group. The study is an early Phase 1 clinical trial designed to better understand this treatment's effects in individuals who have not responded to previous therapies. Participants will undergo several sequential stages including screening, apheresis to collect cells, pre-treatment with lymphodepleting chemotherapy to prepare for the therapy, and treatment with LCAR-AIO T cell infusion. Before receiving the infusion, patients will also receive a conditioning regimen. The study will monitor patients during and after treatment to assess outcomes and safety. Throughout the study, participants will be closely followed for at least 104 weeks after the LCAR-AIO infusion. Researchers will track treatment-emergent adverse events, dose-limiting toxicities within 30 days, pharmacokinetics in the blood, and determine the recommended Phase 2 dose regimen. Assessments will include laboratory tests, clinical evaluations, and ongoing safety monitoring to understand the treatment's impact and tolerability over time.
CONDITIONS
Official Title
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participate in clinical research
- Age 18-65 years
- Diagnosed with systemic lupus erythematosus (SLE) at least 6 months before screening
- Positive antinuclear antibody, anti-dsDNA antibody, or anti-Sm antibody at screening
- Relapsed or refractory SLE condition
- Adequate organ function at screening
- Clinical laboratory values meet criteria at screening
You will not qualify if you...
- Active infections such as hepatitis and tuberculosis
- Other autoimmune diseases
- Serious underlying diseases such as tumors or uncontrolled diabetes
- Female subjects who are pregnant, breastfeeding, or planning pregnancy during the study or within 1 year after treatment
- Participation in other clinical trials within an unspecified recent period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
Q
Qiubai Li, Professor
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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