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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVIVO-TaVec400 product | Experimental | The dose escalation stage includes 4 dose level: DL1，DL2，DL3， DL4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVIVO-TaVec400 product | Biological | Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Maximum 15 years after LVIVO-TaVec400 infusion (Day 1) |
| Maximum concentration (Cmax) in peripheral blood | Maximum concentration (Cmax) in peripheral blood | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1) |
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Inclusion Criteria:
Subjects voluntarily participate in clinical studies.
Age 18-65 years.
Adequate organ function at screening.
Clinical laboratory values meet criteria at screening visit.
r/r SLE:
Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) OR 2012 Systemic lupus international collaborating clinics (SLICC) classification criteria for 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.
r/r IgG4-RD：
Patients meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD.
Fulfill relapsed/refractory IgG4-RD conditions.
Patients have active disease: IgG4-RD Response Index (RI) ≥2.
Progressive MS：
Diagnosis of MS according to 2017 revised McDonald criteria.
Progressive MS according to clinical course criteria revised in 2013.
Presence of Cerebrospinal fluid (CSF) oligoclonal bands (OCBs) or elevated IgG Index at screening.
r/r MG：
Diagnosis of MG.
Myasthenia Gravis Foundation of America (MGFA) Class II-IV.
Positive AChR-IgG or MuSK-IgG at screening.
Fulfill refractory MG conditions.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiubai Li, Professor | Contact | +86-27-85726808 Ext. 027 | qiubaili@hust.edu.cn | |
| Xiangxue Meng | Contact | xiangxue.meng@legendbiotech.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiubai Li | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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| Maximum 5 years after LVIVO-TaVec400 infusion (Day 1) |
| Recommended Dose regimen finding | Determine the Recommended Dose regimen established through dose exploratory. | Maximum 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. | 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. | 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. | 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. | Minimum 104 weeks after LVIVO-TaVec400 infusion (Day 1) |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
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| Shanxi Bethune Hospital | Taiyuan | Shanxi | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008180 | Lupus Erythematosus, Systemic |
| D000077733 | Immunoglobulin G4-Related Disease |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D002908 | Chronic Disease |
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