[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Mabworks Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":213},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,69,90,109,128,148,171,192],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100624156","phase-3-a-phase-3-clinical-study-of-mil62-in-systemic-lupus-erythematosus-100624156",false,"NCT07405970","A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus","A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.","Inclusion Criteria:\n\n1. Age 18-80 ;\n2. Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) SLE classification criteria ;\n3. Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;\n4. High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);\n5. On a stable dose of one or more standard treatments for SLE prior to the first administration；\n6. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Unsufficient organ function;\n2. Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;\n3. Subjects with CD4+ T lymphocyte count \\\u003C 200 cells\u002FμL;\n4. Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;\n5. Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;\n6. TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;\n7. Received live or attenuated vaccination within 28 days prior to the first administration;\n8. Participated in other clinical trials within 28 days prior to the first administration;\n9. Concomitant with other serious diseases;\n10. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV);\n11. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62;\n12. Breastfeeding or pregnant women;\n13. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;\n14. Other conditions unsuitable for participation in this study determined by the Investigator.","ALL","18 Years","80 Years",{"count":20,"type":21},316,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.",[27],"Systemic Lupus Erythematosus","RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":32},"2026-04-10",{"date":36,"type":21},"2028-12",{"name":38,"class":39},"Beijing Mabworks Biotech Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100621833","phase-1-a-study-of-mil116-in-healthy-participants-and-patients-with-iga-nephropathy-100621833","NCT07375758","A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.","A Phase I\u002FII, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy","Inclusion Criteria:\n\n\\-\n\nPhase Ia:\n\n1. Able to understand and voluntarily sign the written Informed Consent Form (ICF), willing and able to comply with all study requirements;\n2. Healthy participants aged 18 to 55 years (inclusive) at the time of signing the ICF, of either sex;\n3. Have a body mass index (BMI) between 19 to 32 kg\u002Fm² (inclusive) and a body weight ≥ 50 kg at screening;\n4. Assessed to be in good health status based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests, with no clinically significant abnormalities;\n5. Have a total immunoglobulin G (IgG) level \\> 10 g\u002FL at screening; and immunoglobulin A (IgA) and immunoglobulin M (IgM) levels within the normal reference ranges.\n\nPhase Ib\\&II:\n\n1. Able to understand and voluntarily sign the written ICF, and willing and able to comply with all study requirements;\n2. Aged ≥ 18 years at the time of signing the ICF, of either sex, with a BMI ≥ 16 kg\u002Fm²;\n3. Biopsy-confirmed diagnosis of IgA Nephropathy (IgAN). Participants must have a 24-hour urine protein-to-creatinine ratio (UPCR) ≥ 0.5 g\u002Fg or 24-hour urine protein ≥ 0.75 g prior to the first dose;\n4. Have been receiving an optimized and stable dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor antagonist (ARB). If currently receiving sodium-glucose cotransporter 2 inhibitors (SGLT2i) and \u002F or endothelin receptor antagonists (ERA), the same administration and dose stability requirements apply for;\n5. Have acceptable hematologic, hepatic, coagulation, and renal function as assessed by clinical laboratory tests.\n\nExclusion Criteria:\n\n\\-\n\nPhase Ia:\n\n1. Nursing, lactating or pregnant, or who have plans to become pregnant during the study\n2. History or evidence of any clinically significant disease, disorder, or condition that, in the investigator's judgment, may pose a risk to the participants' safety, interfere with the study assessments, or render the subject unsuitable for participation, including but not limited to respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurologic, cardiovascular, psychiatric, or other systemic diseases;\n3. Any confirmed or suspected immunosuppressive or immunodeficiency condition, including human immunodeficiency virus (HIV) infection or asplenia; history of recurrent or severe infections, or long-term use of immunosuppressive agents within 6 months prior to screening;\n4. History of chronic infection (e.g., tuberculosis, osteomyelitis) or any infectious disease requiring hospitalization or treatment with antiviral, antibiotic, or antifungal agents within 28 days prior to administration of the study drug;\n5. Use of any prescription medications, over-the-counter (OTC) drugs, herbal products, topical products, or dietary supplements within 28 days prior to administration of the study drug or for within 5 half-lives of the drug (whichever is longer);\n6. Participation in any clinical study of an investigational drug or medical device, or receipt of any investigational study drug, within 3 months prior to administration of the study drug or within 5 half-lives (whichever is longer);\n7. Receipt of any marketed or investigational antibody or biologic therapy (including immunoglobulin products, monoclonal antibodies, or antibody fragments) within 28 days prior to administration of the study drug or within 5 half-lives (whichever is longer);\n8. History of drug abuse or substance dependence, or a positive urine drug abuse screening result during the screening period.\n\nPhase Ib\\&II:\n\n1. Secondary IgAN or IgA vasculitis (Henoch-Schönlein purpura), as diagnosed by the investigator;\n2. Presence of chronic kidney disease of causes other than IgAN;\n3. Other significant pathological abnormalities identified on kidney biopsy;\n4. Kidney biopsy demonstrating tubular-interstitial fibrosis \\> 50% or glomerular crescents involving \\> 25% of glomeruli. Note: The most recent kidney biopsy will be prioritized for eligibility assessment;\n5. Clinical suspicion of rapidly progressive glomerulonephritis based on an estimated glomerular filtration rate (eGFR) decline ≥ 50% within 3 months prior to the screening visit;\n6. Nephrotic syndrome, defined as 24-hour urine protein \\> 3.5 g accompanied by hypoalbuminemia (serum albumin \\\u003C 30 g\u002FL). Subjects with isolated nephrotic-range proteinuria (\\> 3.5 g\u002Fd) are excluded;\n7. Receipt of rituximab or any B-cell depleting agent within 6 months prior to screening. Participants with CD4+ T-cell count \\\u003C 200 cells\u002FμL are excluded;\n8. Total IgG level \\\u003C 6 g\u002FL at screening; uncontrolled type 2 diabetes mellitus, defined as glycated hemoglobin (HbA1c) \\> 8%; or diagnosis of type 1 diabetes mellitus;\n9. History of prior treatment with any APRIL-targeted medication;\n10. Receipt of biologic agents, such as belimumab or eculizumab, within 3 months prior to the first dose of the study drug;\n11. Receipt of cyclophosphamide within 3 months prior to the first dose; use of other immunosuppressive agents within 28 days prior to the first dose, including but not limited to azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, methotrexate, or tripterygium wilfordii; systemic corticosteroids used at an average daily dose equivalent to ≥40 mg prednisone for more than 14 days within 28 days prior to the screening visit, or use of oral delayed-release budesonide capsules within 1 year prior to the screening visit.",true,{"count":50,"type":21},130,[52,53],"PHASE1","PHASE2","This is a Phase I\u002FII study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy.",[56],"Immunoglobulin A Nephropathy",[58,59,60,61],"Anti-APRIL monoclonal antibody","MIL116","IgAN","CLYM116",{"date":63,"type":32},"2026-04-13",{"date":65,"type":32},"2026-02-05",{"date":67,"type":21},"2029-06",{"name":38,"class":39},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":40},"100501195","phase-1-a-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-study-of-mbs303-in-b-cell-nhl-100501195","NCT05806099","A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy Study of MBS303 in B-Cell NHL","A Phase I\u002FⅡ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and to comply with the study protocol.\n2. Adult patients, ≥18 years of age;\n3. CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve survival;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Life expectancy ≥3 months;\n6. Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \\>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \\>1.0 cm in its longest dimension\n7. Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n1. Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;\n2. History of central nervous system (CNS) lymphoma or other CNS disease;\n3. Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);\n4. Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;\n5. Active or suspected autoimmune diseases;\n6. Known severe allergic reaction or\u002Fand infusion reaction to monoclonal antibody;\n7. Evidence of significant, uncontrolled concomitant disease;\n8. Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;\n9. History of another invasive malignant tumors in past 3 years;\n10. Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);\n11. Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;\n12. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);\n13. Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments.",{"count":77,"type":21},132,[52,53],"This is a Phase I\u002FⅡ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)",[81],"Non-Hodgkin's Lymphoma","2024-11-19",{"date":84,"type":32},"2024-11-20",{"date":86,"type":32},"2023-06-28",{"date":88,"type":21},"2026-11",{"name":38,"class":39},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":40},"100426516","phase-3-mil62-combined-with-lenalidomide-versus-lenalidomide-for-patients-with-rituximab-refractory-follicular-lymphoma-100426516","NCT04834024","MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma","A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a\n3. Evidence of refractory to rituximab\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \\> 1.5 cm and a short axis ≥ 10mm\n6. Adequate hematologic function\n7. Life expectancy \\>5 years\n8. Able and willing to provide written informed consent and to comply with the study protocol\n\nExclusion Criteria:\n\n1. Evidence of refractory to lenalinomide\n2. Central nervous system lymphoma\n3. Patients with progressive multifocalleukoencephalopathy (PML)\n4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start\n5. Prior use of any anti-cancer vaccine\n6. Prior administration of radiotherapy 42 days prior to study entry\n7. Prior administration of chemotherapy 28 days prior to study entry\n8. History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix\n9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n10. Known hypersensitivity to thalidomide or lenalidomide\n11. Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to \\\u003C 20 mg\u002Fday prednisone\n12. Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)\n13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )\n14. Pregnant or lactating females",{"count":98,"type":21},168,[24],"This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.",[102],"Follicular Lymphoma and Marginal Zone Lymphoma",{"date":84,"type":32},{"date":105,"type":32},"2021-06-02",{"date":107,"type":21},"2025-03",{"name":38,"class":39},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":40},"100412499","phase-1-a-clinical-study-of-mil95-in-advanced-malignancies-100412499","NCT04651348","A Clinical Study of MIL95 in Advanced Malignancies.","A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Diagnosis of Refractory\u002Frelapsed lymphomas or solid tumor;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Life expectancy \\>=3 months;\n5. Sufficient organ and bone marrow function;\n6. At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);\n7. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;\n2. Previous exposure to any drug targeting CD47 or SIRPα;\n3. Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;\n4. Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;\n5. Central nervous system metastasis;\n6. History of other primary malignant tumors in 5 years;\n7. Evidence of significant, uncontrolled concomitant disease;\n8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );\n9. Active or suspected autoimmune diseases;\n10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments;\n11. Known history of hemolytic anemia;\n12. Known severe allergic reaction or\u002Fand infusion reaction to monoclonal antibody.",{"count":117,"type":21},58,[52],"This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.\n\nThe starting dose for phase Ia part A is 0.1 mg\u002Fkg QW, followed by 3 dose cohorts (0.3mg\u002Fkg QW, 0.8mg\u002Fkg QW and 1mg\u002Fkg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.\n\nPart B will have 5 dose cohorts(3mg\u002Fkg QW, 10mg\u002Fkg QW, 20mg\u002Fkg QW 30mg\u002Fkg QW and 45mg\u002Fkg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.",[121],"Advanced Malignancies",{"date":84,"type":32},{"date":124,"type":32},"2021-01-04",{"date":126,"type":21},"2024-11",{"name":38,"class":39},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":40},"100370972","phase-1-mil62-plus-lenalidomide-for-patients-with-relapsedrefractory-indolent-non-hodgkins-lymphoma-fl-and-mzl-100370972","NCT04110301","MIL62 Plus Lenalidomide for Patients With Relapsed\u002FRefractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)","A Multi-center, Open Label, Phase 1b\u002F2 Study to Study the Efficacy and Safety of MIL62 Plus Lenalidomide in Subjects With Relapsed\u002FRefractory Follicular Lymphoma or Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a\n3. Evidence of progression or lack of response following at least 1 prior treatment\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \\> 1.5 cm and a short axis ≥ 10mm\n6. Adequate hematologic function (unless abnormalities are related to NHL)\n7. Life expectancy \\>6 months\n8. Able and willing to provide written informed consent and to comply with the study protocol\n\nExclusion Criteria:\n\n1. Evidence ongoing transformation into aggressive NHL\n2. Central nervous system lymphoma\n3. Patients with progressive multifocalleukoencephalopathy (PML)\n4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start\n5. Prior use of any anti-cancer vaccine\n6. Prior administration of radiotherapy 42 days prior to study entry\n7. Prior administration of chemotherapy 28 days prior to study entry\n8. History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix\n9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n10. Known hypersensitivity to thalidomide or lenalidomide\n11. Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to \\\u003C 20 mg\u002Fday prednisone\n12. Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)\n13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )\n14. Pregnant or lactating females",{"count":136,"type":21},53,[52,53],"This phase 1b\u002F2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed\u002FRefractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).",[102],[141],"CD20 ,Follicular Lymphoma,Marginal Zone Lymphoma,MIL62",{"date":84,"type":32},{"date":144,"type":32},"2019-11-28",{"date":146,"type":21},"2025-05",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":40},"100350382","phase-1-phase-i-clinical-study-of-mbs301-in-treatment-of-her2-positive-recurrent-or-metastatic-malignant-solid-tumor-100350382","NCT03842085","Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor","Evaluation on Open-Labeled and Dose-Escalation Phase I Clinical Study of Safety and Pharmacokinetics of Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for Injection in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor","Inclusion Criteria:\n\n1. Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.\n2. Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.\n3. Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).\n4. ECOG physical condition: 0 or 1 point.\n5. Expected survival period exceeds 12 weeks.\n\nExclusion Criteria:\n\n1. Absolute neutrophils count (ANC) is less than1.5×109\u002FL and\u002For blood platelets less than 100 ×109\u002FL and\u002For hemoglobin less than 9g\u002FdL.\n2. Total bilirubin is more than 1.5 ×ULN.\n3. Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.\n4. Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance \\\u003C50 mL\u002Fmin(according to Cockcroft-Gault).\n5. International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.\n6. Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg\u002Fm2.\n7. Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).\n8. Known a history with brain metastasis.\n9. Have a history of liver disease of clinical significance.\n10. Known to be human immunodeficiency virus (HIV) positive.",{"count":156,"type":21},34,[52],"This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors",[160],"HER2-positive Recurrent or Metastatic Malignant Solid Tumor",[162,163,164],"HER2-positive","solid tumor","MBS301",{"date":84,"type":32},{"date":167,"type":32},"2019-04-11",{"date":169,"type":21},"2025-12",{"name":38,"class":39},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":40},"100533920","phase-1-a-study-of-mbs314-in-participants-with-relapsedrefractory-multiple-myeloma-100533920","NCT06232096","A Study of MBS314 in Participants With Relapsed\u002FRefractory Multiple Myeloma.","A Phase Ⅰ\u002FⅡ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and to comply with the study protocol;\n2. ≥18 years of age;\n3. Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.\n4. Phase Ⅰb\u002FⅡ: At least one measurable disease: Serum monoclonal paraprotein (M-protein) ≥5 g\u002FL or Urine M-protein ≥200 mg\u002F24 hours or Serum immunoglobulin free-light chains (FLCs) ≥100 mg\u002FL and abnormal kappa\u002Flambda FLC ratio (\\\u003C0.26 or \\>1.65)\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n6. Life expectancy ≥3 months.\n7. Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n1. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n2. Participants with known active infection within 14 days prior to the first MBS314.\n3. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal hepatitis B virus DNA or hepatitis C virus RNA).\n4. Previously received anti-myeloma treatment within the specified time frame prior to the first administration.\n5. Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.\n6. Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.\n7. Participants with a history of autoimmune diseases.\n8. Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.",{"count":179,"type":21},154,[52,53],"This is a Phase I\u002FⅡ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb\u002FⅡ).",[183],"Relapsed or Refractory Multiple Myeloma","2024-03-14",{"date":186,"type":32},"2024-03-15",{"date":188,"type":32},"2024-02-22",{"date":190,"type":21},"2028-03",{"name":38,"class":39},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":40},"100436577","phase-1-treatment-of-advanced-and-metastatic-solid-tumors-with-mil97-100436577","NCT04965077","Treatment of Advanced and Metastatic Solid Tumors With MIL97","A Phase I Multicenter, Open Label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MIL97 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Diagnosis of Refractory\u002Frelapsed metastatic and\u002For unresectable solid tumors;\n3. At least one extracranial measurable unirradiated lesion or evaluable lesion (recist v1.1) ;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy \\>=3 months;\n5. Sufficient organ and bone marrow function within 7 days before enrollment;\n6. Life expectancy \\>=12 weeks;\n7. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. have a history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months before the first dose;\n2. Comorbidity that would interfere with therapy, including interstitial pneumonia, symptomatic congestive heart failure; unstable angina, uncontrolled hypertension; ongoing cardiac arrhythmia ≥ CTCAE 5.0 Grade 3, active coagulopathy, uncontrolled diabetes, QTcF\\>450ms (Male) or QTcF\\>470ms (Female) at screening;\n3. Patients have a known or suspected history of an autoimmune disorder, except for the following: Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are eligible;\n4. Have a history of manifested central nervous system (CNS) metastases or have primary brain tumor. Patients with known or suspected leptomeningeal disease or cord compression;\n5. Receipt of allograft or allogeneic hematopoietic stem cell transplantation;\n6. Patients have another active invasive malignancy, but history of a non-invasive malignancy and history of malignancy that is in complete remission after treatment with curative intent are allowed;\n7. Active known clinically serious infections are required intravenous antibiotic treatment;\n8. Have a history of primary immunodeficiency, including but not limited with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness;\n9. Active and clinical significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C (HCV) (Hepatitis B should be confirmed as HBV surface antigen (HBsAg) positive or HBV core antibody (HBcAb) positive with HBV DNA above ULN);\n10. Any antitumor therapy within prior 4 weeks (including chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy, tumor embolization, etc), except for palliative radiotherapy for relief bone pain;\n11. Major surgery within prior 4 weeks or expected to require major surgery during study treatment (Major surgery: laparotomy, thoracotomy, and internal organs excision by laparoscopic surgery);\n12. Patients have concurrent received or used an immunosuppressive agent within 14 days before study treatment, with the following exceptions and notes: Systemic steroids at physiologic doses, intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption, transient courses of steroids may be approved by the Medical Monitor;\n13. Previous exposure to CD40 antibodies;\n14. Patients received a live attenuated vaccine within 28 days before study treatment and plan to receive live vaccines during the study unless approved by both investigator and sponsor;\n15. Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators;\n16. History of clinically significant sensitivity or allergy to MIL97, their excipients, or intravenous gamma globulin;\n17. Females who are pregnant or lactating or who intend to become pregnant during the clinical trial period and within 6 months after discontinuation of study treatment. Female or Male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment;\n18. Participation in a therapeutic clinical study within 4 weeks for biological treatments, and within 1 week or 5 half-lives for small-molecule agents, before study drug treatment, or current participation in other therapeutic investigational procedures;\n19. Patients who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent are ineligible to participate in the study.",{"count":200,"type":21},62,[52],"This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase.\n\nThe starting dose for dose escalation phase is 0.01 mg\u002Fkg Q3W, followed by 5 dose cohorts (0.03mg\u002Fkg Q3W, 0.1mg\u002Fkg Q3W, 0.2mg\u002Fkg Q3W, 0.3mg\u002Fkg Q3W and 0.45mg\u002Fkg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days.\n\nOne or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.",[204],"Advanced or Metastatic Solid Tumor","2024-03-11",{"date":207,"type":32},"2024-03-13",{"date":209,"type":32},"2022-01-18",{"date":211,"type":21},"2026-12",{"name":38,"class":39},""]