[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639800":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":67,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anselamimab","EXPERIMENTAL","Participants will receive anselamimab (CAEL-101) 1000 mg\u002Fm² by IV infusion weekly for 4 infusions, then every 2 weeks thereafter for up to 48 weeks. Premedication for infusion reaction prophylaxis may be administered according to institutional standards.",[13],"Drug: Anselamimab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Patients will receive anselamimab administered by intravenous infusion. The dose will be 1000 mg\u002Fm² based on body surface area (BSA) calculated from height and weight obtained during screening. BSA will not be recalculated unless body weight changes by ≥20% from screening.\n\nStudy drug will be administered over approximately 2 hours. Participants will receive infusions every 7 (±1) days for the first 4 infusions, followed by every 14 (±2) days thereafter for a total treatment duration of 48 weeks. The maximum single dose is 2700 mg.\n\nParticipants will be monitored for infusion-related reactions and overall tolerability for approximately 90 minutes following completion of the first 4 infusions, or longer at the investigator's discretion.\n\nPremedication with diphenhydramine (25-50 mg PO\u002FIV), acetaminophen\u002Fparacetamol (325-650 mg PO\u002FIV), and\u002For similar agents may be administered per institutional standards to reduce the risk of infusion-related reactions.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Michaela Liedtke, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Mani Gupta","CONTACT","650-723-0501","mgupta4@stanford.edu",[31],{"facility":5,"status":19,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Palo Alto","California","94305","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-122.14302,37.44188,{"lat":41,"lon":40},[44,45],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100639800","early-phase-1-a-pilot-study-of-anselamimab-in-patients-with-al-amyloidoma-and-measurable-tissue-involvement-100639800",false,"NCT07615270","A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement","A Pilot Study of CAEL-101\u002FAnselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement","Inclusion Criteria:\n\n1. AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry\n2. Amyloid deposits are measurable by imaging (ultrasound or cross-sectional)\n3. 18 years or older\n4. ECOG performance status 0-3\n5. Adequate bone marrow reserve, hepatic and renal function as demonstrated by:\n\n   1. Absolute neutrophil count ≥ 1.0 × 109\u002FL\n   2. Platelet count ≥ 75 × 109\u002FL\n   3. Hemoglobin ≥ 9 g\u002FdL\n   4. Total bilirubin ≤ 2 times the upper limit of normal (× ULN) unless due to Gilbert's syndrome.\n   5. Aspartate aminotransferase (AST) ≤ 3 × ULN\n   6. Alanine aminotransferase (ALT) ≤ 3 × ULN\n6. No evidence of cardiac, renal or hepatic involvement by amyloidosis\n\n   1. Echocardiogram with mean wall thickness \\\u003C\u002F= 12mm unless other cardiac cause\n   2. 24 hour urine protein \\\u003C500mg AND estimated glomerular filtration rate (eGFR) \\>50mL\u002Fmin\u002F1.73 sqm (Cockcroft-Gault formula)\n   3. Alkaline phosphatase below upper limit of normal and total liver span \\\u003C\u002F=15cm\n7. Participants of childbearing potential agree to use contraception throughout study an\n8. Ability to understand and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Use of other investigational agents within 30 days of screening\n2. Taking doxycycline within 30 days of screening\n3. Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder.\n4. Major surgery within 4 weeks of enrollment\n5. Pregnant\n6. Breast feeding\n7. Participant is eligible and agreeable to standard of care chemotherapy.\n8. Presence of active infection at the time of screening\n9. Participant with a monoclonal protein or isotypic light chain predominance (increased level of the involved light chain and abnormal free light chain ratio (\\\u003C0.26 or \\>1.65)) ☐\n\n   ☐\n10. Participant with known or suspected systemic AL amyloidosis, or suspicion of other organ involvement.\n11. Lymph node involvement\n12. Involvement of amyloidoma in more than one organ.\n13. AL amyloidoma involving other disease locations except those specified in the protocol\n14. Presence of solitary plasmacytoma\n15. Participant with clinically significant lung disorder or disease\n16. Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.","ALL","18 Years",{"count":58,"type":59},5,"ESTIMATED","INTERVENTIONAL",[62],"EARLY_PHASE1","This is an exploratory study to assess the binding of CAEL-101\u002Fanselamimab to amyloid in vivo, recruitment of inflammatory cells and reduction of the amyloid mass.",[65],"AL Amyloidosis",[9],"NOT_YET_RECRUITING","2026-05-22",{"date":70,"type":71},"2026-05-29","ACTUAL",{"date":73,"type":59},"2026-07",{"date":75,"type":59},"2028-07",{"name":5,"class":6},1]