Anselamimab for adults with AL amyloidoma that affects measurable tissue
Tests anselamimab in adults with AL amyloidosis and measurable tissue involvement.
Plain-language title generated from the registry record
Registry title: A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
Key facts
- Where
- Palo Alto, United StatesSee the site
- Phase
- Early phase 1
Where in United States
- Stanford UniversityPalo Alto, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stanford University
- Trial code
- NCT07615270
- Record updated
- 27 October 2026
- Original description
This is an exploratory study to assess the binding of CAEL-101/anselamimab to amyloid in vivo, recruitment of inflammatory cells and reduction of the amyloid mass.Read full original descriptionShow less
A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
This is an exploratory study to assess the binding of CAEL-101/anselamimab to amyloid in vivo, recruitment of inflammatory cells and reduction of the amyloid mass.
Inclusion: AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry; Amyloid deposits are measurable by imaging (ultrasound or cross-sectional); 18 years or older; ECOG performance status 0-3; Adequate bone marrow reserve, hepatic and renal function as demonstrated by:; Absolute neutrophil count ≥ 1.0 × 109/L; Platelet count ≥ 75 × 109/L; Hemoglobin ≥ 9 g/dL; Total bilirubin ≤ 2 times the upper limit of normal (× ULN) unless due to Gilbert's syndrome; Aspartate aminotransferase (AST) ≤ 3 × ULN; Alanine aminotransferase (ALT) ≤ 3 × ULN; No evidence of cardiac, renal or hepatic involvement by amyloidosis; Echocardiogram with mean wall thickness </= 12mm unless other cardiac cause; 24 hour urine protein <500mg AND estimated glomerular filtration rate (eGFR) >50mL/min/1.73 sqm (Cockcroft-Gault formula); Alkaline phosphatase below upper limit of normal and total liver span </=15cm; Participants of childbearing potential agree to use contraception throughout study an; Ability to understand and willingness to provide written informed consent.
Exclusion: Use of other investigational agents within 30 days of screening; Major surgery within 4 weeks of enrollment; Participant is eligible and agreeable to standard of care chemotherapy; Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma; Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder; Presence of active infection at the time of screening; AL amyloidoma involving other disease locations except those specified in the protocol; Participant with clinically significant lung disorder or disease; Taking doxycycline within 30 days of screening; Pregnant; Breast feeding; Participant with a monoclonal protein or isotypic light chain predominance (increased level of the involved light chain and abnormal free light chain ratio (<0.26 or >1.65)) ☐; ☐; Participant with known or suspected systemic AL amyloidosis, or suspicion of other organ involvement; Lymph node involvement; Involvement of amyloidoma in more than one organ; Presence of solitary plasmacytoma.