Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases
Fred Hutchinson Cancer Center
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.
Description
OUTLINE: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 intravenously (IV) on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil orally (PO) or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone mar…
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalAstatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
Given IV
- DrugFludarabine
Given IV
- DrugCyclophosphamide
Given IV
- BiologicalLapine T-Lymphocyte Immune Globulin
Given IV
- RadiationTotal-Body Irradiation
Undergo TBI
- ProcedureHematopoietic Cell Transplantation
Undergo hematopoietic cell transplantation
- DrugMycophenolate Mofetil
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington