NCT07331272

A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Nanjing Legend Biotech Co. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.

Detailed description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r/r SLE and r/r IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Idiopathic Inflammatory Myopathies(IIM)

Interventions

Type	Name	Description
BIOLOGICAL	LUCAR-G79D T cells	Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Timeline

• Start date: 2026-01-29
• Primary completion: 2028-01-31
• Completion: 2030-01-31
• First posted: 2026-01-09
• Last updated: 2026-02-02

Locations

5 sites across 1 country: China