A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Oct 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called LCAR-AIO for adults who have relapsed or refractory systemic lupus erythematosus (SLE), a chronic autoimmune disease where the immune system mistakenly attacks healthy tissues. The researchers want to see how well this treatment works and whether it can help improve the symptoms in people whose SLE has not responded to other therapies. The trial is currently recruiting participants who are between 18 and 65 years old and have been diagnosed with SLE at least six months prior to the study. Participants need to have specific antibodies in their blood and show signs of the disease that have not improved with previous treatments.

If you join this trial, you will receive the LCAR-AIO treatment, and the study team will monitor your health closely. It’s important to note that certain health conditions may exclude you from participating, such as active infections, other serious autoimmune diseases, or significant underlying health issues. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period will also not be eligible. This trial aims to explore a new approach to treating SLE and could provide valuable information about how to manage this condition better in the future.

Gender

ALL

Eligibility 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