[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Climb Bio, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":150},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,76,99,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":21},"100600388","phase-2-a-phase-2-study-of-budoprutug-in-subjects-with-primary-membranous-nephropathy-100600388",false,"NCT07096843","A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy","A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)","PrisMN","Inclusion Criteria:\n\n* Confirmed diagnosis of PMN with positive anti-PLA2R antibodies\n* CD19+ B cell count ≥40 cells\u002FμL\n* UPCR ≥2.0 g\u002Fg\n* eGFR ≥35 mL\u002Fmin\u002F1.73 m²\n* Stable RAAS inhibitor therapy\n* Blood pressure \\\u003C150\u002F90 mmHg at baseline\n* Adequate hematologic, hepatic, and renal function\n* Willing to use effective contraception (both sexes)\n* Other inclusion criteria may apply\n\nExclusion Criteria:\n\n* Secondary Membranous Nephropathy\n* Rapidly progressive glomerulonephritis or other glomerulopathies\n* Prior B cell-depleting therapy within 24 weeks\n* Recent use of immunosuppressants\n* Active or high-risk infections\n* History of malignancy\n* Pregnancy or breastfeeding\n* Recent major surgery or hospitalization\n* Other exclusion criteria may apply","ALL","18 Years","75 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN",[28],"Primary Membranous Nephropathy",[30,31,15],"PMN","Anti-CD19","RECRUITING","2026-04-28",{"date":35,"type":36},"2026-04-30","ACTUAL",{"date":38,"type":36},"2025-08-25",{"date":40,"type":22},"2027-10",{"name":42,"class":43},"Climb Bio, Inc.","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100636354","phase-1-a-phase-1b2a-study-of-budoprutug-in-systemic-lupus-erythematosus-sle-100636354","NCT07564596","A Phase 1b\u002F2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)","A Phase 1b\u002F2a Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Aged 18 to 65 years at the time of consent.\n2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.\n3. Active, seropositive disease, with SLEDAI 2K \\>=6 at screening\n4. Inadequate response to at least one therapeutic intervention\n\nExclusion Criteria:\n\n1. Active neuropsychiatric SLE.\n2. Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks.\n3. Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study\n4. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.","65 Years",{"count":53,"type":22},30,[55,25],"PHASE1","Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b\u002F2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.",[58],"Systemic Lupus Erthematosus",[60,61,62,63,64,65],"Lupus","SLE","Biologics","Open-label","Monoclonal","anti-CD19","NOT_YET_RECRUITING","2026-04-27",{"date":69,"type":36},"2026-05-04",{"date":71,"type":22},"2026-06",{"date":73,"type":22},"2027-09",{"name":42,"class":43},1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100596322","phase-1-a-phase-1b2a-study-of-budoprutug-in-subjects-with-immune-thrombocytopenia-itp-100596322","NCT07043946","A Phase 1b\u002F2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)","A Phase 1b\u002F2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects With Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Aged 18 years at the time of consent.\n2. Platelet count \\\u003C 30,000\u002FµL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of \\\u003C 30,000\u002FµL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart.\n3. Partial thromboplastin time \\\u003C 1.5 x upper limit of normal (ULN), prothrombin time \\\u003C 1.5 x ULN, total bilirubin \\\u003C 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio \\\u003C 1.5 at screening.\n\nExclusion Criteria:\n\n1. CD19+ B cell count \\\u003C 80 cells\u002FµL at Screening, or \\\u003C 40 cells\u002FµL if B-cell depleting therapy was received within 24 weeks to 2 years prior.\n2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity.\n3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study.\n4. Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed.\n5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days.\n6. IVIg treatment within 90 days prior to Screening.\n7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor.\n8. Active, chronic, or latent infections including hepatitis B\u002FC or HIV.\n9. Active TB or high TB risk.",{"count":84,"type":22},24,[55,25],"The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.",[88,89,62,64,31],"Immune Thrombocytopenia (ITP)","ITP","2026-03-24",{"date":92,"type":36},"2026-03-27",{"date":94,"type":36},"2025-06-30",{"date":96,"type":22},"2028-08",{"name":42,"class":43},20,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100593792","phase-1-a-phase-1b-study-of-budoprutug-in-systemic-lupus-erythematosus-sle-100593792","NCT07011043","A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)","A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Aged 18 to 65 years at the time of consent.\n2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.\n3. Active, seropositive disease, with SLEDAI 2K \\>=8.\n4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.\n\nExclusion Criteria:\n\n1. Active neuropsychiatric SLE.\n2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.\n3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.",{"count":53,"type":22},[55],"The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.",[110],"Systemic Lupus Erythematosus",[60,61,62,63,64,31],{"date":92,"type":36},{"date":114,"type":36},"2025-07-10",{"date":116,"type":22},"2027-04",{"name":42,"class":43},18,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":75},"100612075","phase-1-a-phase-1-study-of-clym116-in-normal-healthy-volunteers-100612075","NCT07248865","A Phase 1 Study of CLYM116 in Normal Healthy Volunteers","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose (SAD) and Multiple-Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection(s) of CLYM116 in Normal Healthy Volunteers","Inclusion Criteria:\n\n* Healthy adult males and females aged 18-60 years, inclusive\n* Body mass index (BMI) between 18 and 32 kg\u002Fm² and weight between 45 and 110 kg\n* Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant)\n* Willing and able to comply with study procedures and provide informed consent\n* Women of childbearing potential must use highly effective contraception and have negative pregnancy tests\n* Men must use contraception and refrain from sperm donation for 4 months post-dose\n* Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months)\n\nExclusion Criteria:\n\n* Prior treatment with investigational drugs within 30 days or 5 half-lives\n* Previous or current hypogammaglobulinemia\n* Current presence of allergic reactions considered clinically significant\n* Positive tests for HIV, hepatitis B\u002FC, syphilis, or tuberculosis\n* Tobacco use (\\>2 cigarettes\u002Fday), alcohol abuse, or drug abuse\n* Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)",true,"60 Years",{"count":129,"type":22},48,[55],"This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.",[133],"Healthy Volunteers",[135,136,137,138,139,140,141],"CLYM116","APRIL","monoclonal antibody","healthy volunteers","Phase 1","IgA nephropathy","MIL116","2026-02-19",{"date":144,"type":36},"2026-02-20",{"date":146,"type":36},"2025-12-02",{"date":148,"type":22},"2026-09",{"name":42,"class":43},""]