A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
Starting soon · Early Phase 1
Conditions studied: AL Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT07615270
- Run by
- Stanford University
- People needed
- 5
- Starts
- 2026-07-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Use of other investigational agents within 30 days of screening
- Taking doxycycline within 30 days of screening
- Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder.
- Major surgery within 4 weeks of enrollment
- Pregnant
- Breast feeding
- Participant is eligible and agreeable to standard of care chemotherapy.
- Presence of active infection at the time of screening
- 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.
- AL amyloidoma involving other disease locations except those specified in the protocol
- Presence of solitary plasmacytoma
- Participant with clinically significant lung disorder or disease
- Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.
Where it is running
- Stanford University — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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