Actively Recruiting
Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases
Led by Fred Hutchinson Cancer Center · Updated on 2025-12-18
40
Participants Needed
1
Research Sites
394 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and younger than 50 years
- Diagnosis of a nonmalignant disease treatable by allogeneic hematopoietic cell transplantation
- Karnofsky performance score of 70 or higher
- Normal liver elastography
- If ferritin is elevated, liver iron concentration less than 7 mg/g by liver T2 MRI
- Underwent official gastrointestinal consultation before transplant
- Have an HLA matched related donor or unrelated donor with specific matching criteria, or an HLA haploidentical donor
- Donor testing performed by a CLIA-approved laboratory
You will not qualify if you...
- Diagnosis of Fanconi Anemia
- Impaired heart function with ejection fraction less than 35% or other specified heart problems
- Impaired lung function with DLCO less than 35% or oxygen saturation below 92% on room air
- Impaired kidney function with creatinine clearance less than 50 ml/min or high serum creatinine, or dialysis
- Impaired liver function with abnormal liver tests or certain liver diseases
- Uncontrolled infection requiring delay of conditioning
- Known HIV infection
- Pregnant or breastfeeding women
- Fertile men or women unwilling to use contraception during and 12 months after treatment
- Allergy to murine-based monoclonal antibodies
- Known contraindication to radiotherapy
- Donor exclusion if positive anti-donor cytotoxic crossmatch or other immunoreactivity risks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
P
Phuong Vo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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