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.
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).
Active infections such as hepatitis and tuberculosis.
Other autoimmune diseases.
Serious underlying diseases such as tumor, uncontrolled diabetes.
Female subjects who were pregnant, breastfeeding.
Single group
LUCAR-G79D T cells
Biological/VaccinePrior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Incidence of dose-limiting toxicity (DLT)
Maximum concentration (Cmax) in peripheral blood
Time of maximum concentration (Tmax) in peripheral blood
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects
SLEDAI-2K is a scale ranging from 0 to 105 points, with higher scores indicating stronger disease activity
Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for r/r IIM subjects
MMT-8 is a scale ranging from 0 to 80 points, with higher scores indicating greater preserved muscle strength
Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects
Including IgG、IgM、IgA、IgE
Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects
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