[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637500":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":20,"overallStatus":81,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Beijing GoBroad Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Part A: Dose Escalation Part, MTM-H-001 Injection, 5 dose groups are planned; the study treatment period includes an induction phase and a maintenance phase.\n\nPart B: Dose Expansion Part, MTM-H-001 Injection, 6 dose cohorts are planned. The dose and frequency for each cohort will be determined based on the safety, PK, and PD data of participants from the dose groups in Part A",[13],"Drug: MTM-H-001 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","MTM-H-001 Injection","Each participant receives MTM-H-001 Injection",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jing Pan, Ph.D","PRINCIPAL_INVESTIGATOR",[26,31],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","+86-010-50847588","869","panj@gobroadhealthcare.com",{"name":32,"role":27,"phone":20,"phoneExt":20,"email":33},"Yusha Huang","yushahuang@MagicTimeMed.onmicrosoft.com",[35],{"facility":5,"status":20,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing","Beijing Municipality","102206","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48,49],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[53],{"name":54,"class":55},"MagicTime Medicine","INDUSTRY","100637500","a-study-to-evaluate-mtm-h-001-injection-in-adult-patients-with-b-cell-related-autoimmune-diseases-100637500",false,"NCT07593911","A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases","An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)","ArchAid-002","Inclusion Criteria:\n\n* Key inclusion criteria include：\n\n  1. Male or female, aged 18 - 75 years old (inclusive);\n  2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n  3. Confirmed diagnosis of the target autoimmune disease per international classification criteria;\n  4. Adequate organ function to tolerate treatment;\n  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n* Key exclusion criteria include:\n\n  1. Active, severe, uncontrolled infection;\n  2. Pregnancy or breastfeeding women;\n  3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;\n  4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.","ALL","18 Years","75 Years",{"count":68,"type":69},75,"ESTIMATED","INTERVENTIONAL",[72],"NA","This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.",[75,76,77,78,79,80],"Systemic Lupus Erthematosus (SLE)","Lupus Nephritis (LN)","Multiple Sclerosis","Myasthenia Gravis (MG)","IgG4-Related Diseases","Rheumatoid Arthritis (RA)","NOT_YET_RECRUITING","2026-05-12",{"date":84,"type":85},"2026-05-18","ACTUAL",{"date":87,"type":69},"2026-06",{"date":89,"type":69},"2031-06",{"name":5,"class":6},1]