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NOT YET RECRUITING

NCT07615270

EARLY_PHASE1

A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07

Completion Date

2028-07

Last Updated

2026-05-29

Healthy Volunteers

Conditions

AL Amyloidosis

Interventions

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.

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 × ULN 6. No evidence of cardiac, renal or hepatic involvement by amyloidosis 1. Echocardiogram with mean wall thickness \</= 12mm unless other cardiac cause 2. 24 hour urine protein \<500mg AND estimated glomerular filtration rate (eGFR) \>50mL/min/1.73 sqm (Cockcroft-Gault formula) 3. Alkaline phosphatase below upper limit of normal and total liver span \</=15cm 7. Participants of childbearing potential agree to use contraception throughout study an 8. Ability to understand and willingness to provide written informed consent. Exclusion Criteria: 1. Use of other investigational agents within 30 days of screening 2. Taking doxycycline within 30 days of screening 3. Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder. 4. Major surgery within 4 weeks of enrollment 5. Pregnant 6. Breast feeding 7. Participant is eligible and agreeable to standard of care chemotherapy. 8. Presence of active infection at the time of screening 9. 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)) ☐ ☐ 10. Participant with known or suspected systemic AL amyloidosis, or suspicion of other organ involvement. 11. Lymph node involvement 12. Involvement of amyloidoma in more than one organ. 13. AL amyloidoma involving other disease locations except those specified in the protocol 14. Presence of solitary plasmacytoma 15. Participant with clinically significant lung disorder or disease 16. Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.

Locations (1)

Stanford University

Palo Alto, California, United States