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Total Body Irradiation and Astatine-211-Labeled BC8-B10 for Nonmalignant Diseases

This study is testing a treatment for nonmalignant (non-cancerous) diseases in people aged 18 to 49 who are having a hematopoietic cell transplant (a procedure to replace unhealthy blood-forming cells with healthy ones). Researchers are looking for the best dose of total body irradiation (radiation to the whole body) combined with a special antibody called astatine-211-labeled BC8-B10 monoclonal antibody. This antibody is designed to target and kill certain cells. You would also receive other medications like fludarabine, cyclophosphamide, and thymoglobulin. The main goal is to see how well these treatments prevent the body from rejecting the new cells after the transplant, with results measured up to 5 years later. The study is currently unclear about its recruitment status and plans to enroll 40 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 40 participants. It is testing a combination of radiation and several medications.
What's involved
You would receive astatine-211-labeled BC8-B10, fludarabine, cyclophosphamide, and thymoglobulin intravenously, undergo total body irradiation, and then have a hematopoietic cell transplant. You would also take mycophenolate mofetil and sirolimus orally for a period. Blood samples and possibly bone marrow aspirations would be collected.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed up at 1 and 2 years, and then periodically for up to 5 years to check for graft rejection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04083183

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

Recruiting
PHASE1Ages 18–49InterventionalTreatment
Fred Hutchinson Cancer Center
~40 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10FludarabineCyclophosphamideLapine T-Lymphocyte Immune GlobulinTotal-Body IrradiationHematopoietic Cell Transplantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft rejection (arm A)
Measured over Up to 5 years post-transplant
+1 more outcome measured

Conditions

Non-Malignant Neoplasm

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NCT04083183

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Phuong Vo · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Phuong Vo
[email protected]
206-667-2749
Email the study team

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Eligibility criteria

Inclusion

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-resolution typing.
HLA haploidentical donor. There must be one shared HLA-haplotype based on inheritance. The noninherited haplotype is allowed to be mismatched at any or all of these loci: HLA-A, B, C, DRB1 or DQB1.
Donor selection guideline recommendations: in the case where there are multiple donor options, donors should be selected based on the following priority numbered below:
Related donor genotypically HLA-matched
Related donor phenotypically HLA-matched
Unrelated donor HLA-matched
Unrelated donor with single allele level mismatch at class 1 (HLA-A, -B, or -C). For example, HLA-A02:01 versus HLA-A 02:02
Unrelated donor with single allele level mismatch at DQB1
HLA-haploidentical donor Note: We require that the donor testing be performed by a United States Clinical Laboratory Improvement Amendment (CLIA) approved laboratory. In the very rare case where the donor testing is not able to be performed in a CLIA approved laboratory, or there is confirmatory testing that needs to be performed, or for any donor identified from Europe and at risk for Creutzfeldt-Jakob Disease (CJD), we note this on the donor screening form and require that the unrelated donor medical director or the attending physician approves the use of the donor HPC-A product under urgent medical need

Exclusion

Patients with Fanconi Anemia
Impaired cardiac function as evidenced by ejection fraction \< 35% (or, if unable to obtain ejection fraction, shortening fraction of \< 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease. Patients with a shortening fraction of \< 26% may be enrolled if approved by a cardiologist. In addition, patients with poorly controlled hypertension on multiple anti-hypertensive medications, symptomatic coronary artery disease, or patients on cardiac medications for antiarrhythmic or inotropic effects are excluded
Impaired pulmonary function as evidenced by carbon monoxide diffusing capability test (DLCO) \< 35% of predicted or receiving supplemental continuous oxygen. In addition, if patients are unable to perform pulmonary function tests, then O2 saturation \< 92% on room air
Impaired renal function as evidenced by estimated creatinine clearance less than 50 ml/min or serum creatinine \> 2 x upper normal limit or dialysis-dependent. Serum creatinine value must be within 28 days prior to start of conditioning
Impaired liver function as evidenced by abnormal hepatic function within 2 months prior to the astatine-211 infusion date defined as a total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \> 2 times the upper limit of normal (with the exception of elevated total bilirubin level, predominantly indirect bilirubin, in patients with hemoglobinopathy due to acute and/or chronic hemolysis). In addition, patients with the following liver abnormalities are excluded: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
An uncontrolled infection requiring deferral of conditioning as recommended by an infectious disease specialist. A viral upper respiratory tract infection does not constitute an uncontrolled infection in this context
Patients who are known to be positive for HIV (human immunodeficiency virus)
Women of childbearing potential who are pregnant or breast-feeding
Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
Allergy to murine-based monoclonal antibodies
Known contraindication to radiotherapy
DONOR EXCLUSION
Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplantation (HCT). If the PRA shows \> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele or class II allele or antigen mismatch or haploidentical donors, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion

What this trial measures

  • Graft rejection (arm A)Up to 5 years post-transplant

    Defined as establishment of \< 5% donor chimerism of CD3+ T cells and \<5% donor chimerism of CD33+ myeloid cells at day 80-100 after hematopoietic cell transplant (HCT) following an human leukocyte antigen (HLA)-matched related or unrelated graft or an unrelated graft with a single HLA-class 1 allele mismatch or DQB1 antigen or allele mismatch.

  • Graft rejection (arm B)Up to 5 years post-transplant

    Defined as establishment of \< 5% donor chimerism of CD3+ T cells and \< 5% donor chimerism of CD33+ myeloid cells at day 80-100 after HCT following an HLA-haploidentical related donor or an unrelated donor mismatched for a single HLA-class 1 antigen or a single HLA-DRB1 allele.