Abstract
This Phase I/II dose-escalation trial evaluates escalating doses of ²¹¹At-BC8-B10 (astatine-211 labeled anti-CD45 monoclonal antibody BC8) administered before allogeneic hematopoietic cell transplantation (HCT) in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), or mixed-phenotype acute leukemia (MPAL). The study aims to determine the maximum tolerated dose (MTD) of ²¹¹At-BC8-B10 when combined with reduced-intensity conditioning, with primary endpoint of regimen-related toxicity grades III/IV assessed up to 100 days post-transplant. Secondary endpoints include engraftment, chimerism, non-relapse mortality, acute GVHD, remission achievement, and overall/disease-free survival up to 2 years. Estimated enrollment of 75 patients with primary completion in June 2027. This trial represents a landmark investigation of alpha-particle therapy in allogeneic HCT for high-risk hematologic malignancies, leveraging the superior cytotoxic properties of alpha particles and CD45-targeting specificity to improve outcomes in patients with refractory disease, measurable residual disease, or relapsed leukemia.
Publication Information
Source: ClinicalTrials.gov
Trial Registration Date: April 25, 2017
Last Update Posted: June 18, 2025
Trial ID: NCT03128034
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT03128034
Authors
Sponsor: Fred Hutchinson Cancer Center
Principal Investigator: Brenda M. Sandmaier, MD
Contact: Phone: 206-667-4961; Email: bsandmai@fredhutch.org
Institutional Affiliation: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
Phase: Phase I/II
Estimated Enrollment: 75 patients
Study Timeline: October 24, 2017 – March 31, 2029 (estimated)
Funding: National Cancer Institute (NCI); NIH Grant P01CA078902; Fred Hutch/University of Washington Cancer Consortium
Key Publications: Li Y, Hamlin DK, Chyan MK, et al. cGMP production of astatine-211-labeled anti-CD45 antibodies for use in allogeneic hematopoietic cell transplantation. PLoS One. 2018;13(10):e0205135.