[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639761":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":46,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":19,"overallStatus":69,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BL-M11D1","EXPERIMENTAL","Participants receive BL-M11D1 for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[13],"Drug: BL-M11D1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Administration by intravenous infusion for a cycle of 4 weeks.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Sa Xiao, PHD","CONTACT","15013238943","xiaosa@baili-pharm.com",[27],{"facility":28,"status":19,"city":29,"state":30,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences","Tianjin","Tianjin Municipality","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.17667,39.14222,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Zhijian Xiao","022-23909083","zjxiao@ihcams.ac.cn",{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[47],{"name":48,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100639761","phase-1-a-study-of-bl-m11d1-in-patients-with-relapsedrefractory-myelodysplastic-syndromes-100639761",false,"NCT07591168","A Study of BL-M11D1 in Patients With Relapsed\u002FRefractory Myelodysplastic Syndromes","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M11D1 for Injection in Patients With Relapsed\u002FRefractory Myelodysplastic Syndromes","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restrictions;\n3. Age: ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Relapsed\u002Frefractory CD33+ MDS;\n6. Morphological assessment showing blasts in bone marrow ≥5% and \\\u003C20%;\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;\n8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n9. Meet the required organ function levels;\n10. For premenopausal women of childbearing potential, a pregnancy test (serum\u002Furine) must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled trial participants (regardless of gender) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. Presence of uncorrected folate deficiency or vitamin B12 deficiency, etc.;\n3. History of severe cardiovascular or cerebrovascular disease;\n4. Thromboembolic events requiring therapeutic intervention within 6 months prior to screening;\n5. Active autoimmune diseases and inflammatory diseases;\n6. History of extensive bowel resection or presence of Crohn's disease, ulcerative colitis, chronic diarrhea, or intestinal obstruction;\n7. Diagnosis of another malignancy within 5 years prior to the first dose;\n8. Poorly controlled hypertension;\n9. Poorly controlled hyperglycemia or diabetes mellitus;\n10. Pulmonary diseases classified as Grade ≥3 according to CTCAE v6.0, etc.;\n11. Trial participants with central nervous system involvement;\n12. Trial participants with extramedullary involvement;\n13. Trial participants with a history of allergy to recombinant humanized antibodies or chimeric human-mouse antibodies, or hypersensitivity to any excipient component of BL-M11D1;\n14. Prior organ transplantation or hematopoietic stem cell transplantation;\n15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n16. Active fungal, bacterial, or viral infections;\n17. History of severe neurological or psychiatric disorders;\n18. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n19. Presence of clinically symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage;\n20. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;\n21. Pregnant or breastfeeding women;\n22. Other conditions deemed by the investigator to make the participant unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":60,"type":61},92,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","This study is an open-label, multicenter, non-randomized Phase Ib\u002FII clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BL-M11D1 for injection in patients with relapsed\u002Frefractory myelodysplastic syndromes.",[68],"Myelodysplastic Syndromes","NOT_YET_RECRUITING","2026-05-09",{"date":72,"type":73},"2026-05-15","ACTUAL",{"date":75,"type":61},"2026-05",{"date":77,"type":61},"2028-12",{"name":5,"class":6},1]