NCT06866080

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Autoimmune Diseases (r/r AID)

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nanjing Legend Biotech Co. · Industry
• 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 autoimmune diseases.

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 autoimmune diseases. 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

• Relapsed/Refractory Autoimmune Diseases

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: 2025-06-17
• Primary completion: 2025-06-17
• Completion: 2025-06-17
• First posted: 2025-03-10
• Last updated: 2025-07-08

Locations

4 sites across 1 country: China