RecruitingEarly Phase 1NCT06653556

A Study of LCAR-AIO in Subjects With Relapsed/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)

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

34 participants

Start Date

Jan 8, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus (SLE)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

Subjects voluntarily participate in clinical research.
Age 18-65 years.
Have been diagnosed of SLE at least 6 months before screening.
At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.
Fulfill relapsed/refractory SLE conditions.
Adequate organ function at screening.
Clinical laboratory values meet criteria at screening.

Exclusion Criteria5

Active infections such as hepatitis and tuberculosis.
Other autoimmune diseases.
Serious underlying diseases such as tumor, uncontrolled diabetes.
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.
Participated in other clinical trials within