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Recruiting Phase 1, Phase 2 NCT04083183

Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases

Trial Parameters

Condition Non-Malignant Neoplasm
Sponsor Fred Hutchinson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 49 Years
Start Date 2020-06-16
Completion 2028-01-09
Interventions
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10FludarabineCyclophosphamide

Brief Summary

This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive/toxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells.

Eligibility Criteria

Inclusion Criteria: * Age \>= 18 years and \< 50 years * Nonmalignant disease treatable by allogeneic hematopoietic cell transplantation (HCT). Patients with a nonmalignant disease that is not clearly defined must be approved by the principal investigator (PI) * Karnofsky score \>= 70 * Patients must have normal elastography * If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI) * Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation * DONOR INCLUSION * HLA matched related donor that is genotypically or phenotypically identical for HLA-A, -B, -C, -DRB1, -DQB1. Phenotypic identity must be confirmed by high-resolution typing. Sibling donors are preferred over other relationships * Unrelated donor. * Matched for HLA-A, -B, -C, -DRB1, and DQB1 by high-resolution typing; OR * Mismatched for a single HLA-class 1 allele or HLA-DQB1 antigen or allele by high-resolut

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