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| Name | Class |
|---|---|
| Bioray Laboratories | INDUSTRY |
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This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCMA CAR-T Group | Experimental | Universal BCMA CAR-T |
|
| CD19 CAR-T Group | Experimental | Universal CD19 CAR-T |
|
| BCMA CAR-T + CD19 CAR-T Group | Experimental | Universal BCMA CAR-T; Universal CD19 CAR-T |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Universal BCMA CAR-T | Drug | Universal BCMA CAR-T |
| |
| Universal CD19 CAR-T |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities(DLTs) | Incidence of dose-limiting toxicities(DLTs) | First 28 days after infusion |
| Incidence of adverse events(AEs) and severe adverse | Incidence of adverse events(AEs) and severe adverse events(SAEs). | Up to 12 months after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of UCAR-T cells | The concentration of BCMA UCAR T cells and CD19 UCAR-T cells in peripheral blood after infusion | 3 months |
| B cell levels in peripheral blood | The change of B cell levels in peripheral blood after infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junwei Hao, MD;PhD | Contact | 01083198277 | haojunwei@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
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| Drug |
Universal CD19 CAR-T |
|
| Universal BCMA CAR-T; Universal CD19 CAR-T | Drug | Universal BCMA CAR-T; Universal CD19 CAR-T |
|
| 3 months |
| Changes of pathogenic antibody titers after infusion | The changes of pathogenic antibody titers in peripheral blood or cerebrospinal fluid. | 1, 3, 6 ,12months |
| NMOSD: Annualized relapse rate | ARR is defined as the number of relapses divided by the total participant-years after infusion | 6, 12months |
| gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score | MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG. | 1, 3, 6, 12months |
| CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion. | The INCAT score assesses the functionality of the arms and legs by giving a 0-5 score for arms and legs, with 0 representing no disability and 5 representing no arm function or inability to stand/walk. | 1, 3, 6, 12months |
| MS: Changes of the number of Gd-enhancing T1 Lesions | The changes of enhancing Lesions as detected by brain Magnetic Resonance Imaging (MRI) | 6, 12months |
| MS: Changes of the number of Number of New or Enlarging T2 Lesions | Number of new/enlarging T2 lesions on last available MRI scan compared to baseline. | 6, 12months |
| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| D009157 | Myasthenia Gravis |
| D009103 | Multiple Sclerosis |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| 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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