[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630664":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-3836 for injection","EXPERIMENTAL",null,[13],"Drug: SHR-3836 administered as multiple doses.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","SHR-3836 administered as multiple doses.","* In the dose escalation phase, doses are escalated sequentially from low to high levels.\n* In the dose expansion phase, one or more selected dose levels are further evaluated.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Depei Wu","CONTACT","+0512-67976372","drwudepei@163.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The First Affiliated Hospital of Soochow University","RECRUITING","Suzhou","Jiangsu","215006","China","CN",{"type":36,"coordinates":37},"Point",[38,39],120.59538,31.30408,{"lat":39,"lon":38},[42],{"name":22,"role":43,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630664","phase-1-a-phase-i-study-of-shr-3836-in-patients-with-multiple-myeloma-100630664",false,"NCT07490613","A Phase I Study of SHR-3836 in Patients With Multiple Myeloma","An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female\n2. Expected survival ≥ 3 months\n3. ECOG performance status 0 or 1\n4. Diagnosed with active multiple myeloma per IMWG criteria\n5. Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.\n6. Disease progression or non-response to the most recent therapy\n7. Measurable disease as defined by serum\u002Furine M-protein or serum free light chain\n8. Adequate bone marrow, hepatic, renal, and coagulation function\n9. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception\n10. Willing and able to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n1. Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.\n2. Central nervous system involvement by tumor.\n3. History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.\n4. Requirement for dialysis or plasmapheresis within 14 days prior to study drug.\n5. Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).\n6. Concurrent participation in another clinical study.\n7. Prior anti-tumor therapy within specified washout periods.\n8. Major surgery within 28 days prior to informed consent or planned during the study.\n9. Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.\n10. Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.\n11. Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).\n12. Active infection.\n13. Known hypersensitivity or contraindication to SHR-3836.","ALL","18 Years",{"count":56,"type":57},99,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).",[63],"Multiple Myeloma","2026-06-02",{"date":66,"type":67},"2026-06-04","ACTUAL",{"date":64,"type":67},{"date":70,"type":57},"2029-04",{"name":5,"class":6},1]