Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 5:47 PM
Study NCT ID:
NCT07413835
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'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': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 3 months', 'description': 'Proportion and severity of adverse events (AEs)'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in Myasthenia Gravis Activities of Daily Living（MG-ADL） score', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of patients ≥2 points. A total score can fall between 0 and 24, with a higher score representing a more significant degree of disease activity'}, {'measure': 'Changes from baseline in Myasthenia Gravis Composite （MGC） score', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of patients ≥3-point reduction.The total score is 50 points. The higher the score, the more severe the condition is indicated.'}, {'measure': 'Changes from baseline in Quantitative Myasthenia Gravis (QMG) score', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of patients ≥3-point reduction. To assess the muscle strength and endurance of the affected muscles in patients with myasthenia gravis, thereby reflecting the severity of the disease.'}, {'measure': 'Changes from baseline in 15-item quality of life (MG-QOL15r) score', 'timeFrame': 'Up to 12 months', 'description': "To assess important aspects of the patient's experience related to MG, scores each of 15 items 0-2 (max score 30)."}, {'measure': 'Percentage of patients with symptom changes after treatment', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of patients without symptom worsening or relapse'}, {'measure': 'in vivo CAR T cell production', 'timeFrame': 'Day-28 to14 days', 'description': 'Assessment of CAR T production (CAR expression ratio in T cells) in the peripheral blood of MG patients by flow cytometry (FACS)'}, {'measure': 'B cell ratio and counts in peripheral blood', 'timeFrame': 'Up to 12 months', 'description': 'Assessment of B cell ratio and counts (B cell counts per μl peripheral blood) and B cell subsets(naive B cell, memory B cell) by flow cytometry (FACS) in peripheral blood'}, {'measure': 'Dynamic changes in cytokine levels after treatment', 'timeFrame': 'Up to 12 months', 'description': 'Differences in cytokine post-administration vs. baseline'}, {'measure': 'Changes in acetylcholine receptor (AchR) antibody levels after treatment', 'timeFrame': 'Up to 12 months', 'description': 'Differences in AchR antibody post-administration vs. baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MG', 'HN2302'], 'conditions': ['Refractory Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'This is an open label, single arm study, to evaluate the safety , tolerability and preliminary efficacy of HN2302 for refractory myasthenia gravis.', 'detailedDescription': 'The study will consist of an up to 4-week Screening Period, Treatment Period and one year Follow-up Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18-80 years, no gender restriction;\n* Confirmed diagnosis of generalized myasthenia gravis (MG) with positive AchR or MuSK antibodies, meeting at least one of the following conditions：(1) Repetitive nerve stimulation suggesting neuromuscular transmission defect; (2) Positive response to neostigmine test; (3) Clinically judged improvement of --MG symptoms after oral cholinesterase inhibitor therapy;\n* Clinical classification of MG according to MGFA types IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa, IVb);\n* Baseline MG-ADL score ≥6, ocular-related score \\<50%;\n* Poor response and/or lack of efficacy under standard therapies;\n* Minimum life expectancy \\> 12 weeks;\n* Adequate bone marrow, coagulation, cardiopulmonary, liver, and renal function.\n\nExclusion Criteria:\n\n* Subjects positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA, positive for hepatitis C antibody (HCV Ab) with detectable or quantifiable HCV RNA, positive for HIV antibody, positive CMV DNA, or CMV DNA above the lower limit of detection; positive for syphilis antigen or antibody;\n* Presence of other uncontrolled active infections;\n* History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women;\n* Receipt of any mRNA-LNP products or other LNP-based drugs within the past two years;\n* History of any of the following cardiovascular conditions within 6 months prior to screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac disease;\n* History of ≥Grade 2 bleeding events within 30 days prior to screening, or requiring long-term continuous anticoagulation therapy (e.g., warfarin, low molecular weight heparin, Xa factor inhibitors);\n* History of live vaccination within 30 days prior to screening;\n* Severe central nervous system diseases or pathological changes, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or psychosis;\n* History of asthma or severe allergies;\n* Any condition that, in the investigator's opinion, may increase the patient's risk or interfere with study assessments."}, 'identificationModule': {'nctId': 'NCT07413835', 'briefTitle': 'Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG)', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HN2302 in Patients With Refractory Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'HN2302-N04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HN2302 treatment group', 'description': 'Started at a lower dose level', 'interventionNames': ['Drug: HN2302 Injection']}], 'interventions': [{'name': 'HN2302 Injection', 'type': 'DRUG', 'otherNames': ['in vivo CAR-T'], 'description': 'Patients will be administrated with specified dose on specified days at a lower dose level and escalated to safe and effective dose levels.', 'armGroupLabels': ['HN2302 treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221000', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Zhang', 'role': 'CONTACT', 'email': 'zy20037416@163.com', 'phone': '86-0516-85802193'}], 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Yong Zhang', 'role': 'CONTACT', 'email': 'zy20037416@163.com', 'phone': '86-0516-85802193'}], 'overallOfficials': [{'name': 'Guiyun Cui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}, {'name': 'Yong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shenzhen MagicRNA Biotechnology Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}