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.
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
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
Single group
Anselamimab
DrugPatients 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.
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