A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
Stanford University
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry 2. Amyloid deposits are measurable by imaging (ultrasound or cross-sectional) 3. 18 years or older 4. ECOG performance status 0-3 5. Adequate bone marrow reserve, hepatic and renal function as demonstrated by: 1. Absolute neutrophil count ≥ 1.0 × 109/L 2. Platelet count ≥ 75 × 109/L 3. Hemoglobin ≥ 9 g/dL 4. Total bilirubin ≤ 2 times the upper limit of normal (× ULN) unless due to Gilbert's syndrome. 5. Aspartate aminotransferase (AST) ≤ 3 × ULN 6. Alanine aminotransferase (ALT) ≤ 3 ×…
Interventions
- DrugAnselamimab
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.
Location
- Stanford UniversityPalo Alto, California