NCT06653556

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)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
BIOLOGICAL	LCAR-AIO T cells	Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.

Timeline

• Start date: 2025-01-08
• Primary completion: 2027-09-30
• Completion: 2029-09-30
• First posted: 2024-10-22
• Last updated: 2025-01-10

Locations

1 site across 1 country: China