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)
Nanjing Legend Biotech Co.
38 participants
Jan 29, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- Subjects voluntary agreement to provide written informed consent.
- Aged 18 to 70 years, either sex.
- Adequate organ function meet screening criteria.
- Positive test for cluster of differentiation antigen 19 (CD19).
- SLE:
- Have been diagnosed of SLE at least 6 months before screening.
- At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
- Fulfill relapsed/refractory SLE conditions.
- IIM:
- Have been diagnosed of IIM before screening.
- Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
- Fulfill relapsed/refractory IIM conditions.
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.
- Those with a history of major organ transplantation.
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Interventions
Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07331272