[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"monoclonal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:monoclonal":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":4,"leadSponsor":39,"locationsCount":42},"100061328","study-of-factors-regulating-mast-cell-proliferation-100061328",false,"NCT00044122","Study of Factors Regulating Mast Cell Proliferation","Regulation of the Proliferation and Survival of Normal and Neoplastic Human Mast Cells","* PATIENT PARTICIPANT INCLUSION CRITERIA:\n\nParticipants with mastocytosis zero to 80 years of age may participate in telehealth visits, and two to 80 years of age may participate on-site at NIH Clinical Center.\n\nHistologic evidence of increased mast cell number by bone marrow and\u002For skin biopsy or documentation of mastocytosis in the skin\n\nsupported with a photograph of diagnostic skin lesions\n\nMust be under the care of a primary care physician to be enrolled.\n\nAbility to provide informed consent.\n\nPATIENT PARTICIPANT EXCLUSION CRITERIA:\n\nAnemia with hemoglobin less than 8 g\u002FdL, hematocrit less than 24.\n\nAny condition that in the opinion of the investigator contraindicates participation in this study.\n\nRELATIVE INCLUSION CRITERIA:\n\nTwo to 80 years of age.\n\nA biological relative without the diagnosis of mastocytosis by skin examination or histologic evidence in a skin or bone marrow biopsy\n\nParticipant has a primary medical care provider outside the NIH\n\nAbility to provide informed consent.\n\nRELATIVE EXCLUSION CRITERIA:\n\nAny condition that in the opinion of the investigator contraindicates participation in this study.",true,"ALL","1 Day","80 Years",{"count":21,"type":22},600,"ESTIMATED","OBSERVATIONAL","This study will examine growth factors that promote and inhibit mast cell proliferation resulting in mastocytosis, a disease of excessive mast cells in the body. These cells can release chemicals that cause itching, blisters, flushing, bone pain and abdominal pain.\n\nPatients up to 80 years of age with mastocytosis may be eligible for this 1-day study. Participants will have one visit at NIH lasting up to 8 hours, during which they will undergo the following tests and procedures:\n\n* Medical history and physical examination.\n* Laboratory studies, if medically indicated.\n* Blood tests to identify genetic changes important in the growth, development, and functioning of mast cells.\n* Bone marrow aspiration and biopsy.\n\nFor the bone marrow procedure, the skin over the hipbone and the outer surface of the bone itself are numbed with local anesthesia. Then, a special needle is inserted into the hipbone and about 1 tablespoon of bone marrow is drawn into a syringe. Another needle is inserted into the same area to collect a small piece of the bone marrow. Additional procedures may include allergen testing, urinalysis, and 24-hour urine collection.\n\nParticipants will receive an evaluation of their mastocytosis.\n\n...",[26,27,28,29],"Mastocytosis","Monoclonal","Bone Marrow","Tryptase",[26,31],"Natural History","RECRUITING","2026-06-27",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2002-09-18",{"name":40,"class":41},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"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.","18 Years",{"count":52,"type":22},24,"INTERVENTIONAL",[55,56],"PHASE1","PHASE2","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.",[59,60,61,27,62],"Immune Thrombocytopenia (ITP)","ITP","Biologics","Anti-CD19","2026-03-24",{"date":65,"type":36},"2026-03-27",{"date":67,"type":36},"2025-06-30",{"date":69,"type":22},"2028-08",{"name":71,"class":72},"Climb Bio, Inc.","INDUSTRY",20]