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| Name | Class |
|---|---|
| Shanghai Xiniao Biotech Co., Ltd. | INDUSTRY |
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This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.
This is an investigator-initiated trial to evaluate the safety and efficacy of universal CD19/BCMA CAR T-cells in Relapsed or Refractory Neurological Autoimmune Diseases.
Study intervention consists of a single infusion of universal CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Interim analysis will be performed when participants finish the visit 90 days after CAR T-cell infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCAR T-cell group | Experimental | Universal allogeneic CD19/BCMA CAR T-cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCAR T-cell | Drug | Universal allogeneic anti-CD19/BCMA CAR T-cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of dose-limiting toxicity (DLT) events | DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. | Within 28 Days After UCAR T-cell Infusion |
| The total number, incidence, and severity of AEs | Up to 90 days After UCAR T-cell Infusion |
| Measure | Description | Time Frame |
|---|---|---|
| NMOSDăMS: Expanded Disability Status Scale (EDSS) score | EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialing Wu | Contact | 86-18622271026 | wywjl2009@hotmail.com | |
| Guanen Zhou | Contact | 86-13920273016 | tjzge@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Huanhu Hospital | Recruiting | Tianjin | China |
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| Up to 24 Months After UCAR T-cell Infusion |
| NMOSDăMS: Modified Rankin Scale | Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to 6. | Up to 24 Months After UCAR T-cell Infusion |
| MG: Quantitative Myasthenia Gravis Score (QMG) | The QMG score is a 13-item scale used to quantify disease severity in myasthenia gravis. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits). | Up to 24 Months After UCAR T-cell Infusion |
| MG: Myasthenia Gravis Activities if Daily Living (MG-ADL) Score | The MG-ADL is an eight-question survey of symptom severity, with each response graded from 0 (normal) to 3 (most severe). Two questions concern ocular, three oropharyngeal, one respiratory, and two extremity functions. Cumulative MG-ADL scores range from 0 to 24 | Up to 24 Months After UCAR T-cell Infusion |
| CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score | The INCAT score comprises two parts, the arm score and the leg score. Based on a patient's level of impairment in their arms and legs, each part is scored between 0 and 5 points, resulting in an INCAT total score between 0 and 10. | Up to 24 Months After UCAR T-cell Infusion |
| AE: Change in CASE | The changes of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score from baseline. | Up to 24 Months After UCAR T-cell Infusion |
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| D009157 | Myasthenia Gravis |
| D009103 | Multiple Sclerosis |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| D020274 | Autoimmune Diseases of the Nervous System |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D011129 | Polyradiculoneuropathy |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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