Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-27 @ 4:57 AM
Study NCT ID:
NCT06939166
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}, {'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-04-14', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number and severity of dose-limiting toxicity (DLT) events', 'timeFrame': 'Within 28 Days After UCAR T-cell Infusion', 'description': '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.'}, {'measure': 'The total number, incidence, and severity of AEs', 'timeFrame': 'Up to 90 days After UCAR T-cell Infusion'}], 'secondaryOutcomes': [{'measure': 'NMOSD、MS: Expanded Disability Status Scale (EDSS) score', 'timeFrame': 'Up to 24 Months After UCAR T-cell Infusion', 'description': '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.'}, {'measure': 'NMOSD、MS: Modified Rankin Scale', 'timeFrame': 'Up to 24 Months After UCAR T-cell Infusion', 'description': '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.'}, {'measure': 'MG: Quantitative Myasthenia Gravis Score (QMG)', 'timeFrame': 'Up to 24 Months After UCAR T-cell Infusion', 'description': '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).'}, {'measure': 'MG: Myasthenia Gravis Activities if Daily Living (MG-ADL) Score', 'timeFrame': 'Up to 24 Months After UCAR T-cell Infusion', 'description': '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'}, {'measure': 'CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score', 'timeFrame': 'Up to 24 Months After UCAR T-cell Infusion', 'description': "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."}, {'measure': 'AE: Change in CASE', 'timeFrame': 'Up to 24 Months After UCAR T-cell Infusion', 'description': 'The changes of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Universal Allogeneic CAR T-cells'], 'conditions': ['Neuromyelitis Optica Spectrum Disorders', 'Myasthenia Gravis', 'Multiple Sclerosis', 'Chronic Inflammatory Demyelinating Polyradiculoneuropathy', 'Autoimmune Encephalitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudy intervention consists of a single infusion of universal CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.\n\nInterim analysis will be performed when participants finish the visit 90 days after CAR T-cell infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.\n* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Subjects with a history of severe drug allergies or allergic tendencies.\n* History of malignancy within five years.\n* Subjects with insufficient cardiac function.\n* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n* Pregnant women or women planning to conceive."}, 'identificationModule': {'nctId': 'NCT06939166', 'briefTitle': 'Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Huanhu Hospital'}, 'officialTitle': 'A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases', 'orgStudyIdInfo': {'id': 'QH-HH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UCAR T-cell group', 'description': 'Universal allogeneic CD19/BCMA CAR T-cells', 'interventionNames': ['Drug: UCAR T-cell']}], 'interventions': [{'name': 'UCAR T-cell', 'type': 'DRUG', 'description': 'Universal allogeneic anti-CD19/BCMA CAR T-cells', 'armGroupLabels': ['UCAR T-cell group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jialing Wu', 'role': 'CONTACT', 'email': 'wywjl2009@hotmail.com', 'phone': '86-18622271026'}, {'role': 'CONTACT', 'email': 'tjzge@163.com'}, {'name': 'Jialing Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guanen Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Jialing Wu', 'role': 'CONTACT', 'email': 'wywjl2009@hotmail.com', 'phone': '86-18622271026'}, {'name': 'Guanen Zhou', 'role': 'CONTACT', 'email': 'tjzge@163.com', 'phone': '86-13920273016'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Huanhu Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Xiniao Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jialing Wu', 'investigatorAffiliation': 'Tianjin Huanhu Hospital'}}}}