[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649791":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":27,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":27,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":27,"studyType":66,"phases":67,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":85,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Cullinan Therapeutics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Dose Escalation.","EXPERIMENTAL","Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose escalation cohorts.",[13],"Drug: Velinotamig specified dose on specified days.",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: Dose Expansion.","Patients with relapsing and refractory immune thrombocytopenia and warm autoimmune hemolytic anemia with velinotamig in dose expansion cohorts.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Velinotamig specified dose on specified days.","Velinotamig is an engineered bispecific antibody directed against BCMA and CD3.",[9,15],[25,26],"CLN-803","GR1803",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Shane McLoughlin","CONTACT","+16178609878","ClinOps@cullinantx.com",[35],{"facility":36,"status":27,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Cullinan Investigative Site","Webster","Texas","77598","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-95.11826,29.53773,{"lat":46,"lon":45},[49],{"name":36,"role":31,"phone":50,"phoneExt":27,"email":33},"+6178609878",{"type":52,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100649791","phase-1-a-phase-1b2a-study-of-velinotamig-in-adults-with-relapsedrefractory-itp-and-waiha-100649791",false,"NCT07738822","A Phase 1b\u002F2a Study of Velinotamig in Adults With Relapsed\u002FRefractory ITP and wAIHA","A Phase 1b\u002F2a, Open-label Study of Velinotamig for the Treatment of Adults With Relapsing and Refractory Immune Thrombocytopenia and Warm Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Age ≥18 to 80 years\n* Active autoimmune cytopenia\n* Relapsed\u002Frefractory after standard of care therapy\n* ECOG performance status 2 or lower\n\nLaboratory parameters including the following:\n\n* Absolute lymphocyte count (ALC) ≥0.5 × 109\u002FL\n* Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL\n* Hemoglobin ≥6.5 g\u002FdL\n* Total bilirubin ≤1.5 × ULN unless related to Gilbert's syndrome\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN, unless attributable to hemolysis\n* Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥30 mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History of clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with subject safety, study evaluations, and\u002For study procedures, would put the patient at undue risk or confound study results\n* Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminate interferon gamma release assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB\n* Presence of New York Heart Association class III or IV congestive heart\n* Primary immunodeficiency or history of recurrent infections\n* Previous treatment with a BCMA-targeted therapy\n* Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1\n* History of solid organ transplant\n* Planned major surgery in the timeframe of the dosing period","ALL","18 Years","80 Years",{"count":64,"type":65},72,"ESTIMATED","INTERVENTIONAL",[68,69],"PHASE1","PHASE2","A Phase 1b\u002F2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) to evaluate safety and tolerability.",[72,73],"Immune Thrombocytopenia (ITP)","Warm Autoimmune Hemolytic Anemia (WAIHA)",[75,76,77,78,79,80,81,82,83,84],"Autoimmune disease","Blood platelet disorder","Thrombocytopenia","Anemia","Hemolytic anemia","Red blood cell disorder","Autoimmune cytopenia","Warm Autoimmune Hemolytic Anemia","Immune Thrombocytopenia","Immune Thrombocytopenic Purpura","NOT_YET_RECRUITING","2026-07-28",{"date":88,"type":89},"2026-07-31","ACTUAL",{"date":91,"type":65},"2026-12",{"date":93,"type":65},"2031-01",{"name":5,"class":6},1]