[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655858":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":58,"overallOfficials":32,"centralContacts":86,"locations":92,"responsibleParty":120,"collaborators":122,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":32,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":32,"studyType":138,"phases":139,"briefSummary":142,"conditions":143,"keywords":32,"overallStatus":145,"whyStopped":32,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":32},[9,13],{"measure":10,"description":11,"timeFrame":12},"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-M08D1.","Up to approximately 24 months",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20,23,26,29],{"measure":18,"description":19,"timeFrame":12},"Complete Remission Rate (CRR)","Complete Remission Rate (CRR) refers to the proportion of patients in a clinical trial who achieve a complete remission (CR) after receiving a specific treatment.",{"measure":21,"description":22,"timeFrame":12},"Progression-free Survival (PFS)","Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.",{"measure":24,"description":25,"timeFrame":12},"Disease Control Rate (DCR)","Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.",{"measure":27,"description":28,"timeFrame":12},"Duration of Response (DOR)","Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.",{"measure":30,"description":31,"timeFrame":12},"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-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40,53],{"label":41,"type":42,"description":43,"interventionNames":44},"BL-M08D1+R-GemOx or BL-M08D1+R-CHOP","EXPERIMENTAL","Participants receive BL-M08D1+R-GemOx or BL-M08D1+R-CHOP for the first cycle (3 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.",[45,46,47,48,49,50,51,52],"Drug: BL-M08D1","Drug: Rituximab","Drug: Gemcitabine Hydrochloride","Drug: Oxaliplatin","Drug: Cyclophosphamide","Drug: Doxorubicin Hydrochloride Liposome","Drug: Vincristine Sulfate","Drug: Prednisone Acetate Tablets",{"label":54,"type":55,"description":56,"interventionNames":57},"R-GemOx or R-CHOP","ACTIVE_COMPARATOR","Participants receive R-GemOx or R-CHOP for the first cycle (3 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.",[46,47,48,49,50,51,52],[59,64,67,70,73,76,79,82],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":32},"DRUG","BL-M08D1","Administration by intravenous infusion for a cycle of 3 weeks.",[41],{"type":60,"name":65,"description":62,"armGroupLabels":66,"otherNames":32},"Rituximab",[41,54],{"type":60,"name":68,"description":62,"armGroupLabels":69,"otherNames":32},"Gemcitabine Hydrochloride",[41,54],{"type":60,"name":71,"description":62,"armGroupLabels":72,"otherNames":32},"Oxaliplatin",[41,54],{"type":60,"name":74,"description":62,"armGroupLabels":75,"otherNames":32},"Cyclophosphamide",[41,54],{"type":60,"name":77,"description":62,"armGroupLabels":78,"otherNames":32},"Doxorubicin Hydrochloride Liposome",[41,54],{"type":60,"name":80,"description":62,"armGroupLabels":81,"otherNames":32},"Vincristine Sulfate",[41,54],{"type":60,"name":83,"description":84,"armGroupLabels":85,"otherNames":32},"Prednisone Acetate Tablets","Oral administration for a cycle of 3 weeks.",[41,54],[87],{"name":88,"role":89,"phone":90,"phoneExt":32,"email":91},"Sa Xiao, PHD","CONTACT","+86 15013238943","xiaosa@baili-pharm.com",[93,108],{"facility":94,"status":32,"city":95,"state":96,"zip":32,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","China","CN",{"type":100,"coordinates":101},"Point",[102,103],113.25,23.11667,{"lat":103,"lon":102},[106],{"name":107,"role":89,"phone":32,"phoneExt":32,"email":32},"Qingqing Cai",{"facility":109,"status":32,"city":110,"state":111,"zip":32,"country":97,"countryCode":98,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"The First Affiliated Hospital of Soochow University","Suzhou","Jiangsu",{"type":100,"coordinates":113},[114,115],120.59538,31.30408,{"lat":115,"lon":114},[118],{"name":119,"role":89,"phone":32,"phoneExt":32,"email":32},"Depei Wu",{"type":121,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[123],{"name":124,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100655858","phase-1-a-study-of-bl-m08d1-in-combination-with-immunochemotherapy-in-patients-with-diffuse-large-b-cell-lymphoma-100655858",false,"NCT07818499","A Study of BL-M08D1 in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma","A Phase Ib\u002FII Clinical Study to Evaluate the Efficacy and Safety of BL-M08D1 for Injection in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. No gender restriction;\n3. Age ≥18 years and ≤75 years;\n4. Expected survival time ≥3 months;\n5. Patients with diffuse large B-cell lymphoma;\n6. Agree to provide archived tumor tissue specimens within 3 years or fresh tissue samples;\n7. Must have at least one measurable lesion;\n8. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;\n9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n11. Organ function levels must meet the requirements;\n12. Urine protein ≤1+ or \\\u003C1000 mg\u002F24h;\n13. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be breastfeeding; all enrolled trial participants must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;\n14. Trial participants must be able and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;\n2. History of severe heart disease or cerebrovascular disease within 6 months before screening;\n3. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n4. Active autoimmune diseases and inflammatory diseases;\n5. Diagnosis of active malignancy within 5 years prior to the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;\n7. Hypertension inadequately controlled by antihypertensive medications;\n8. Trial participants with poorly controlled blood glucose;\n9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of grade ≥2;\n10. Use of glucocorticoids at a dose \\>30 mg\u002Fday prednisone or equivalent, for purposes other than control of lymphoma symptoms;\n11. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;\n12. Patients with central nervous system involvement;\n13. Previous or current central nervous system disorders;\n14. Contraindications to any component of the study intervention, including but not limited to previous allergic reactions;\n15. Receipt of autologous hematopoietic stem cell transplantation or CAR-T cell therapy, etc., within 12 weeks prior to the first dose;\n16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;\n18. Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks prior to the first study drug administration;\n19. Imaging findings indicating that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, pharynx, etc., or the pericardium or heart;\n20. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;\n21. Pregnant or breastfeeding women;\n22. Other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment in this clinical trial.","ALL","18 Years","75 Years",{"count":136,"type":137},204,"ESTIMATED","INTERVENTIONAL",[140,141],"PHASE1","PHASE2","This Phase Ib\u002FII study is a clinical trial to explore the efficacy and safety of BL-M08D1 for injection in combination with immunochemotherapy in patients with diffuse large B-cell lymphoma.",[144],"Diffuse Large B-Cell Lymphoma","NOT_YET_RECRUITING","2026-09-08",{"date":148,"type":149},"2026-09-14","ACTUAL",{"date":151,"type":137},"2026-09",{"date":153,"type":137},"2028-12",{"name":5,"class":6},2]