[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639761":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":60,"studyPopulation":53,"armGroups":61,"interventions":68,"overallOfficials":53,"centralContacts":73,"locations":79,"responsibleParty":95,"collaborators":97,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":53,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":53,"studyType":113,"phases":114,"briefSummary":117,"conditions":118,"keywords":53,"overallStatus":120,"whyStopped":53,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":53},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Phase Ib: Recommended Phase II Dose (RP2D)","The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M11D1.","Up to approximately 24 months",{"measure":14,"description":15,"timeFrame":12},"Phase Ib: Treatment-Emergent Adverse Event (TEAE)","TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and\u002For intensity) of a pre-existing condition during the treatment of BL-M11D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M11D1.",{"measure":17,"description":18,"timeFrame":12},"Phase II: Objective Response Rate (ORR)","ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.",{"measure":20,"description":21,"timeFrame":12},"Phase II: Complete Response (CR)","Complete Response (CR) is defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) having a short axis diameter reduced to \\\u003C10 mm.",[23,26,29,32,35,38,41,44,47,50],{"measure":24,"description":25,"timeFrame":12},"Cmax","Maximum serum concentration (Cmax) of BL-M11D1 will be investigated.",{"measure":27,"description":28,"timeFrame":12},"Tmax","Time to maximum serum concentration (Tmax) of BL-M11D1 will be investigated.",{"measure":30,"description":31,"timeFrame":12},"T1\u002F2","Half-life (T1\u002F2) of BL-M11D1 will be investigated.",{"measure":33,"description":34,"timeFrame":12},"AUC0-t","AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.",{"measure":36,"description":37,"timeFrame":12},"CL (Clearance)","CL in the serum of BL-M11D1 per unit of time will be investigated.",{"measure":39,"description":40,"timeFrame":12},"Ctrough","Ctrough is defined as the lowest serum concentration of BL-M11D1 prior to the next dose will be administered.",{"measure":42,"description":43,"timeFrame":12},"ADA (anti-drug antibody)","Frequency of anti-BL-M11D1 antibody (ADA) will be investigated.",{"measure":45,"description":46,"timeFrame":12},"Phase II: Duration of Response (DOR)","The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.",{"measure":48,"description":49,"timeFrame":12},"Phase II: Hematologic Improvement (HI)","HI is defined as achieving a predefined threshold of improvement in the erythroid, platelet, or neutrophil lineages according to the IWG 2006 and IWG 2023 criteria, with a duration of no less than 8 weeks.",{"measure":51,"description":52,"timeFrame":12},"Phase II: AML Transformation Rate","The AML transformation rate is defined as the first confirmed event of transformation to acute myeloid leukemia according to WHO criteria (bone marrow blasts ≥20% or presence of extramedullary infiltration).",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"NA","SINGLE_GROUP","TREATMENT",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE","The study consists of two phases: a dose-exploration phase (Phase Ib) and a dose-expansion phase (Phase II).",[62],{"label":63,"type":64,"description":65,"interventionNames":66},"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.",[67],"Drug: BL-M11D1",[69],{"type":70,"name":63,"description":71,"armGroupLabels":72,"otherNames":53},"DRUG","Administration by intravenous infusion for a cycle of 4 weeks.",[63],[74],{"name":75,"role":76,"phone":77,"phoneExt":53,"email":78},"Sa Xiao, PHD","CONTACT","15013238943","xiaosa@baili-pharm.com",[80],{"facility":81,"status":53,"city":82,"state":83,"zip":53,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences","Tianjin","Tianjin Municipality","China","CN",{"type":87,"coordinates":88},"Point",[89,90],117.17667,39.14222,{"lat":90,"lon":89},[93],{"name":94,"role":76,"phone":53,"phoneExt":53,"email":53},"Zhijian Xiao",{"type":96,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[98],{"name":99,"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":111,"type":112},92,"ESTIMATED","INTERVENTIONAL",[115,116],"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.",[119],"Myelodysplastic Syndromes","NOT_YET_RECRUITING","2026-08-25",{"date":123,"type":124},"2026-08-27","ACTUAL",{"date":126,"type":112},"2026-09",{"date":128,"type":112},"2028-12",{"name":5,"class":6},1]