An Early Phase 1 interventional study of LCAR-AIO T cells in Systemic Lupus Erythematosus (SLE), sponsored by Wuhan Union Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-10.
Sponsored by Wuhan Union Hospital, China · Early Phase 1, Interventional, and Treatment
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 34 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Experimental: Chimeric antigen receptor T cells (LCAR-AIO) Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level
Biological: LCAR-AIO T cells
Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Incidence of dose-limiting toxicity (DLT)
DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.
Time frame: 30 days after LCAR-AIO infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through dose exploratory.
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks
The SELENA-2K scale is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-2K total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Change in Physician global assessment (PGA) scores from baseline up to 104 weeks
The physician will place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (Score 0) represents "no activity", and the right-hand boundary (score 3) represents "the most severe activity".
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion
Percentage of participants achieving the LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \<=4, with no activity in major organ systems (Central nervous system, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) Physician global assessment (PGA) (score 0-3), \<=1; (4) current prednisolone (or equivalent) dose \<=7.5 mg dailyultiple visits.
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
24h urinary protein/urine protein-to-creatinine ratio (UPCR) changes from baseline up to 104 weeks
Proteinuria will be assessed in lupus nephritis patients basing on 24h urinary protein/UPCR at multiple visits.
Time frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody)
Detection of Immunoglobulins, anti-drug antibodies (anti-dsDNA antibody, anti-Sm antibody, etc.) and anti-drug antibody.
Time frame: Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Plan to share: No
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Lupus Erythematosus, Systemic→
Wuhan Union Hospital, China