Journal
BLOOD
Volume 116, Issue 13, Pages 2241-2244Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2010-03-273797
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Funding
- FDA [FD-R-003420]
- National Cancer Institute/National Institute of Diabetes and Digestive and Kidney Diseases [CA10056]
- Aslan Foundation
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Care of patients with AL amyloidosis currently is limited by the lack of objective means to document disease extent, as well as therapeutic options that expedite removal of pathologic deposits. To address these issues, we have initiated a Phase I Exploratory IND study to determine the biodistribution of the fibril-reactive, amyloidolytic murine IgG1 mAb 11-1F4 labeled with I-124. Patients were infused with less than 1 mg (similar to 74 MBq) of GMP-grade antibody and imaged by PET/CT scan 48 and 120 hours later. Among 9 of 18 subjects, there was striking uptake of the reagent in liver, lymph nodes, bone marrow, intestine, or, unexpectedly, spleen (but not kidneys or heart). Generally, positive or negative results correlated with those obtained immunohistochemically using diagnostic tissue biopsy specimens. Based on these findings, we posit that I-124-mAb m11-1F4 can be used to identify AL candidates for passive immunotherapy using the chimeric form of the antibody. This trial was registered at www.clinicaltrials.gov as NCT00807872. (Blood. 2010;116(13):2241-2244)
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