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A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
Sponsor: Nanjing Legend Biotech Co.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2026-01-29
Completion Date
2030-01-31
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
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.
Locations (5)
The Third The People's Hospital of Bengbu
Bengbu, Anhui, China
Nanfang Hospital
Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China