Treatment for patients with relapsed or refractory systemic lupus erythematosus
An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)
This study is testing a new CAR-T cell therapy to see if it can help adults with relapsed or hard-to-treat systemic lupus erythematosus feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chimeric antigen receptor, chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06653556 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and effectiveness of LCAR-AIO, a CAR-T cell therapy, in adults suffering from relapsed or refractory systemic lupus erythematosus (SLE). Participants will undergo a series of procedures including screening, apheresis, lymphodepleting chemotherapy, and LCAR-AIO infusion. The study aims to explore the pharmacokinetics and efficacy of this innovative treatment approach. It is designed as a single-arm, open-label study, meaning all participants will receive the same treatment without a control group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of systemic lupus erythematosus who have experienced relapses or refractory symptoms.
Not a fit: Patients with active infections, other autoimmune diseases, or serious underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat systemic lupus erythematosus.
How similar studies have performed: While CAR-T cell therapies have shown promise in other conditions, this specific application for systemic lupus erythematosus is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhan, Hubei
- Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Qiubai Li, Professor
- Email: qiubaili@hust.edu.cn
- Phone: 85726808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.