This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.
This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the LVIVO-TaVec400, an in vivo chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. The subject who meets the defined eligibility criteria will follow the sequential stages: screening, treatment (LVIVO-TaVec400 infusion) and follow-up (Up to 15 years).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The 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 has a causal relationship with the treatment and will limit the dose escalation.
Time frame: 28 days after LVIVO-TaVec400 infusion (Day 1)
The incidence, severity of Adverse events (AEs)
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 13 weeks after LVIVO-TaVec400 infusion (Day 1)
The incidence, severity of Treatment-related Adverse event (TRAE)
An treatment-related adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which has a causal relationship with the treatment.
Time frame: Maximum 15 years after LVIVO-TaVec400 infusion (Day 1)
Maximum concentration (Cmax) in peripheral blood
Maximum concentration (Cmax) in peripheral blood
Time frame: Maximun 5 years after LVIVO-TaVec400 infusion (Day 1)
Time of maximum concentration (Tmax) in peripheral blood
Time of maximum concentration (Tmax) in peripheral blood
Time frame: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)
Area under the concentration-time curve (AUC) in peripheral blood
Area under the concentration-time curve (AUC) in peripheral blood
Time frame: Maximum 5 years after LVIVO-TaVec400 infusion (Day 1)
Recommended Dose regimen finding
Determine the Recommended Dose regimen established through dose exploratory.
Time frame: Maximum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline for r/r SLE subjects
The SLEDAI-2K scale is a cumulative index used to assess disease activity across 24 different disease descriptors in patients with SLE. A total score ranges between 0 and 105, with a higher score representing a more significant degree of disease activity.
Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
Change in IgG4-RD Response Index (IgG4-RD RI) from baseline for r/r IgG4-RD subjects
The IgG4-RD scale is a cumulative index used to assess disease activity across 25 different disease descriptions in patients with IgG4-RD. A total score ranges between 0 and 75, with a higher score representing a more significant degree of disease activity.
Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
Change in Expanded Disability Status Scale (EDSS) scores from baseline for PMS subjects.
The EDSS is a scoring system used to quantify and monitor the progression of physical disability in patients with multiple sclerosis. The total score ranges from 0 to 10, with higher scores representing a worse outcome.
Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores from baseline for r/r MG subjects.
The MG-ADL is a patient-reported tool that quantifies the severity of myasthenia gravis symptoms based on daily functions. The total score ranges from 0 to 24, with higher scores representing a worse functional status.
Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
Change in Quantitative Myasthenia Gravis (QMG) scores from baseline for r/r MG subjects.
The QMG is a standard clinical tool used to quantify the severity of myasthenia gravis through objective muscle testing. The total score ranges from 0 to 39, with higher scores representing a worse clinical status.
Time frame: Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1)
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