An Early Phase 1 interventional study of Anselamimab in AL Amyloidosis, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Stanford University · Early Phase 1, Interventional, and Treatment
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.
Adequate bone marrow reserve, hepatic and renal function as demonstrated by:
No evidence of cardiac, renal or hepatic involvement by amyloidosis
Exclusion Criteria:
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)) ☐
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Participants will receive anselamimab (CAEL-101) 1000 mg/m² 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.
Drug: Anselamimab
Patients will receive anselamimab administered by intravenous infusion. The dose will be 1000 mg/m² 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. Study 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. Participants 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. Premedication with diphenhydramine (25-50 mg PO/IV), acetaminophen/paracetamol (325-650 mg PO/IV), and/or similar agents may be administered per institutional standards to reduce the risk of infusion-related reactions.
Change From Baseline in Amyloid Target Lesion Size
Amyloid target lesion size will be assessed using RECIST v1.1 criteria. Measurements will be obtained at baseline and at Weeks 12, 24, 36, 48, and 72. The outcome will evaluate change from baseline in target lesion size.
Time frame: Baseline through Week 72
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Immunoglobulin Light-chain Amyloidosis→
Stanford University