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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
The Third The People's Hospital of Bengbu
Bengbu, Anhui, China
RECRUITINGNanfang Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGIncidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: 2 years after LUCAR-G79D infusion (Day 1)
Incidence of dose-limiting toxicity (DLT)
Time frame: 2 years after LUCAR-G79D infusion (Day 1)
Maximum concentration (Cmax) in peripheral blood
Time frame: 2 years after LUCAR-G79D infusion (Day 1)
Time of maximum concentration (Tmax) in peripheral blood
Time frame: 2 years after LUCAR-G79D infusion (Day 1)
Area under the concentration-time curve (AUC) in peripheral blood
Time frame: 2 years after LUCAR-G79D infusion (Day 1)
Recommended Dose regimen finding
Time frame: 2 years after LUCAR-G79D infusion (Day 1)
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
Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)
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
Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)
Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGIncluding IgG、IgM、IgA、IgE
Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)
Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects
Time frame: 52 weeks after LUCAR-G79D infusion (Day 1)